How to manage Design and Development according to ISO 13485 of medical devices?

The design and development procedure for medical devices is not as simple as in other manufacturing industries. Design and development for medical devices has to deal with relevant regulations, product safety, and risk controls on product flaws in addition to the normal application needs, specification needs, and end consumer’s needs. The criticality of the design and development procedure is that if the medical device be unsuccessful to meet regulatory design requirements, it won’t be able to reach the market.

An inappropriate design is not merely an imperfect design in a medical device product lifecycle; instead, it means the product can be dangerous to patients and, then, the product can be rejected by the regulatory body due to its imperfect design, damaging the image of the medical device supplier. ISO 13485:2016 helps to carry out medical device design activities in efficient and controlled manner.

Design and development procedure management:

ISO 13485:2016 increases some new requirements within the scope of design and development, such as design and development transfer records and design files. The necessities for design and development are:

Procedure: The organization is essential to document all the logical stages in design and development in a well-structured procedure, defining responsibilities for different activities, with approving authorities.

Planning: The planning segment is the most important segment of design and development, because good planning can stop unnecessary delays. In the planning segment the organization should identify the aim and objectives of the design and development of the product, the breakdown of chief activities with risk management activities, the timeline of single activities and the complete project, and the allocation of resources required in each segment of design and development.

Inputs: The quality of design and development inputs are important for making the right outputs. The organization should contain as inputs are as follows:

·         Planned application.

·         Usability requirements.

·         Consumer and end user requirements.

·         Physical features, and manufacturing probability.

·         Ergonomics and safety features.

·         Risk control and risk moderation techniques.

·         Past complaints, failure reports.

·         Appropriate regulatory, legal, and statutory requirements and proper standards.

·         Sterilization requirements and servicing requirements.

·         Economic study and costing probability.

Outputs: The organization can produce design outputs in the following methods:

·         Raw materials, component parts, sub-assemblies, and complete device specifications in drawings.

·         Manufacturing procedure and environmental specifications.

·         Process for quality assurance that explains acceptance criteria.

·         Product identification, traceability, manufacturing, packaging, and examination procedures.

·         Documentation for submission to the supervisory authorities where devices will be marketed.

·         Design history file to prove design was verified and validated.

Review: The design review is a detailed step that addresses a number of manufacturing and consumer concerns. For illustration, the organization wants to prove whether the design meets product requirements or not, whether the device design exhibits compatibility with processing capabilities, whether safety concerns are addressed, whether it is ecologically friendly, and whether materials, facilities, components, and service elements are adequate or not. Design reviews are usually done in a meeting, and minutes should be maintained.

Verification: Design verification is a essentials requirement. It confirms that design outputs meet the specified requirements of inputs. The organization can verify designs with the help of tests, additional calculations, comparing proven designs, inspections, and reviews of documents like specifications records, drawings, procedures, reports, etc.

Validation: Design validation is a segment that comes after design verification. It is a segment that assures that the medical device obeys to end user requirements and the application. Validation is done on samples from originally produced lots. The product is authorized in simulated conditions where its actual performance is tested.

Transfer: An organization essential document a procedure to transfer design and development outputs to manufacturing. This is not just handing off and taking over of design from product development to the manufacturing department. Rather, it means that product development has assures that the design can be translated to production and records of such transfer are maintained.

Control of Changes: The procedure for design and development of the medical devices should contain a mechanism to control design and development changes. A design change can be required at any time based on review, verification, validation, complaints, manufacturing issues, etc. Previous to change enforcement, it should be revised, verified, validated, and permitted against design inputs and requirements.

Design and Development Files: The organization should maintain a design and development file for every medical device design. The file may contain reference records of conformism to design requirements, records of review, verification, validation, and changes.

ISO 13485 Medical devices - Quality management systems requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems. The ISO 13485 Certification which helps to implement the medical device preventive system. The ISO 13485 certification confirms a very safe use of medical devices as per quality system guidelines.

How to determine regulatory requirements according to ISO 13485 Quality Management System for Medical Devices?

 

It doesn’t matter if organization has applied ISO 13485 or not, obeying with regulatory requirements is critical to production and service delivery in the medical device industry. If you want business to be successful, then need to understand the regulatory requirements that affect to product and service. Such regulations confirm the safety and efficiency of medical devices, and although some requirements may be seen as a burden, they really are in the best attention of both consumers and dealers.

Where do regulatory requirements come from?

ISO 13485 quality management system covers regulatory requirements in the same breath as consumer requirements right from the start. Clarification of Concept states: When the term regulatory requirements is used, it contains requirements confined in any law appropriate to the user of this International Standard. The request of the term ‘regulatory requirements’ is limited to requirements.

The purpose for this is the effect that regulatory requirements have on an organization’s ability to deliver its products or services. The ISO 13485 standard needs the organization to determine which regulatory requirements are relevant to its Quality Management System, and the effects they can have on the QMS. Regulatory bodies set requirements relating to several aspects of the medical device industry, with product and service provision, utilization of raw materials, communication with consumers, and other elements of an organization’s operations. An absence of compliance, whether knowingly or not, can result in serious consequences—not the minimum of which are expensive fines and injury or death to a patient.

Almost everybody in the industry understands the importance of these regulations, but it can sometimes be hard to identify all appropriate requirements. Generally, need to study the regulatory authorities in own country, as well as those in any other countries to which provide products or service. Let’s look in more detail at which groups need to pay attention to when trying to identify regulatory requirements:

Regulatory bodies: Every nation has a regulatory body that supervises the medical device industry. Organizations delivering medical device products or services must meet the requirements the FDA will cancel the organization’s license to work in the United States.

Acts: In some countries, Acts regulate the providing of medical devices and services. One such Directive is the European Commission’s Medical Device Directive, which sets requirements connected to expected levels of durability and performance in medical devices in Europe. Like the regulatory requirements mentioned above, there can be high costs related with failure to obey with Acts and Directives.

Medical device legal devices: Many countries have statutory instruments regulating the medical device industry. In Ireland, this is statutory instrument No. 252/1994 – European Communities Regulations, 1994, and all producers and suppliers of medical devices in Ireland must also obey with these requirements.

What is the connection between regulatory requirements and ISO 13485?

According to ISO 13485 certification, as with any other international standard, shows stakeholders and interested parties that an organization goes over and above appropriate legal requirements, holding itself to a higher standard. An organization cannot be obedient with the standard if it does not meet regulatory requirements.

ISO 13485 contains a handful of requirements that deal with the knowledge should have gained while identifying applicable regulatory requirements. After all, understand such requirements in order to carry out Quality Management System procedures correctly. Some of these requirements contain:

•     The QMS must contain the requirements for roles undertaken by the organization for applicable regulatory bodies.
•      Advisory notices must be made available to appropriate regulatory bodies.
•    Traceability of measurement must be maintained according to the needs of relevant regulatory bodies.
•     Requirements for products and services should contain requirements from applicable regulatory bodies.
•     The design and development process to consider the requirements of regulatory bodies, such as the level of control that is expected in the procedure.
•     Management review must contain reports to regulatory bodies as inputs and as outputs, any essential changes in response to new or changing problems with regard to relevant regulatory bodies.

An appropriately planned QMS contains relevant regulatory requirements:

The first step along path of ISO 13485 implementation, and becoming more competitive in market, is understanding and complying with regulatory requirements. By doing so, organization will be well equipped to deliver safe products and services, and prevent the problems related with noncompliance. The ISO 13485:2016 standard gives a solid foundation for identifying applicable regulatory requirements, and measuring organization’s level of obedience.

Key Steps Involved in ISO 13485 Internal Auditing Practices

ISO 13485:2016 specifies necessities for a quality management system where an organization wants to prove its capability to deliver medical devices and related services that constantly meet consumer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, with design and development, production, storage and supply, installation, or servicing of a medical device and design and development or provision of associated activities. ISO 13485:2016 can also be used by suppliers or external parties that deliver product, including quality management system-related services to such organizations.

The ISO 13485 internal audit process as one more essential evil required for ISO 13485 certification and maintenance. Some think of it as a waste of time, simply duplicating the work of the certification body; others see it as a witch hunt, looking for mistakes, or searching for someone to blame or discipline. In truth, the internal audit is neither of these things, these are certainly not the intent.

Steps to Follow During ISO 13485 Audit

The purpose of the internal audit is to inspect processes more closely and try to identify areas for improvement. As a process owner, it can be very helpful to step away for a moment and permit a second set of eyes to look for opportunities that may have missed. The purpose is not to criticize, but rather to find ways to streamline processes so that they work more efficiently. So, here are the five key steps in the internal audit process, with tips for how to best use this process to the advantage of company.

·     Plan and announce the ISO 13485 audit schedule: The audit is not about surprising people so “catch them in the act” of doing something wrong. When do that, top management sends a clear message that they don’t trust their employees, and in turn, employees may try to protect themselves by hiding data or giving false information. So, with this in mind, it is significant to set up a clear audit schedule, and make sure that everybody knows when each process will be audited – even if it’s just a rough guideline to start. The ISO 13485 Audit shows an assurance from management to supporting employees in their efforts to improve their processes. It also permits those in charge of a process to finish up any improvements they are currently working on, so they can get a clear view of the influence of those changes, and also process owners may wish to make special requests for the auditor to look for particular information associated to other planned improvements.

·    Plan the individual process audits: Now that everybody has an idea of when to expect an ISO 13485 audit, need to plan and schedule the audits of each individual process. This permits both auditor and auditee to find a time that works for each, and a timeline that is comfortable. This is also a good time to go over previous ISO 13485 audit checklist reports to determine what follow-up might be required, and to talk about any areas that either party would like to pay extra attention to. Taking the time to plan the audit well is the best way to make sure that both the company and the process owner will advantage from the audit process.

·      Conduct the ISO 13485 audit: To begin, the auditor and process owner should meet to discuss the audit plan, and make sure it is complete and ready to go. Then, the auditor can go to work gathering the evidence they want to determine whether the process is functioning as it should, according to the Quality Management System for Medical devices, and if it is producing the desired results. This information can be assembled through analyzing key process data, reviewing records, talking with employees, or observing the process itself. During the process, it is appreciated if the ISO 13485 auditor can point out any areas that do not have sufficient evidence that they are functioning as expected, or any areas they notice that could be enhanced.

·    Report on the audit: The ISO 13485 audit is complete, then the auditor should hold a closing meeting with the process owner to communicate any findings right away, such as any faintness in the process, any particularly positive observations, or any areas that are functioning as expected, but that could be better. A written report should be provided as documentation.

·     Improvements: Of course, just like any other part of the QMS in medical device manufacturers, improvements are key to a successful audit. If problems were found, and corrective actions taken, it is critical to follow up and assure that the problems were truly addressed. If improvement projects were implemented based on opportunities found during the audit, then assembly data to see just how much the process has enhanced will motivate employees and management to look for more opportunities for improvement.

The internal audit as a necessary evil for maintaining compliance in the organization, a management or quality personnel can use the ISO 13485 internal auditor training as a way to understand, monitor and improve upon company’s processes. As ISO 13485 places heavy emphasis on process improvement within the Quality Management System, this should be a key motivator for company, not to mention the other benefits that go along with improvement, like enhanced efficiency in terms of costs and time. Allow internal audit to bring value to QMS, and to company.

Mandatory Steps for Effective ISO 13485 Certification

ISO 13485:2016 specifies for a quality management system where an organization wants to prove its capability to deliver medical devices and associated services that constantly meet client and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, with design and growth, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities. ISO 13485:2016 can also be used by sellers or external parties that provide product, including quality management system-related services to such organizations.

Who is ISO 13485 for?

ISO 13485 is designed to be used by organizations complex in the design, production, installation and service of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help with their auditing processes.

Steps to follow during ISO 13485 Certification

To confirm medical products will pass certification, here are the key steps that organization should follow during the ISO 13485 implementation and certification:

·         Conduct a Gap Analysis:

This is an audit that controls the level of compliance versus the standards that are being held.

·         Develop a project plan:

After the audit and gap analysis, describe a corrective plan which lists all non-conformities, including how to fix problems to comply with ISO 13485 necessities and related regional standard implementation.

·         Develop documentation:

Put together the ISO 13485 documents that includes a Quality Manual, procedures, work instructions and documentation with proof of implementation.

·         Develop & conduct training:

This is one of the most significant steps in checklist. Delivery of training to anyone who will be complicated in any stage of the production of the medical device is mandatory. The first training educates the team on appropriate requirements of the ISO 13485 standards, with those relevant to regional and product certifications. The next training is to set in place a Quality Management System that delivers a standard for complying with work instructions and required sanitary procedures, as well as recording of proof of execution on specific documentation.

·         System Implementation:

A period of three to six months is specified to implement the new Quality Management System as per ISO 13485 requirements and preparation of documentation to prove compliance.

·         Conduct an internal audit:

The dealer should conduct an internal medical device audit to measure agreement and accurate any noted deviations. Internal audit can also be performed by a third-party auditor.

·         Conduct a management review:

If the Quality Management System is not executed according to ISO 13485 procedure, and does not meet the well-defined policy and objectives, it must be adjusted to meet the essential requirements.

·         Apply for ISO 13485 certification:

An external audit of ISO 13485 is the concluding step. This external audit is typically directed by certification bodies. Based on the willingness of organization, the certification body will issue the ISO 13485 certificate if pass, or issue a non-conformance report that will need corrective actions. Once all non-conformance items are closed, the organization can then re-apply for certification.

ISO 13485 Certifications Supports Medical Device Companies:

The medical device sector is a high-pressure industry where people admiration innovation as long as it doesn’t sacrifice user safety. Moreover, creators must respond to demand spikes, as examples like the flow in ventilator needs during the COVID-19 pandemic showed. Getting an ISO 13485 certification can help a business make positive, permanent quality and process developments. Thus, representatives from certified companies often find that ISO 13485 contributes to organizational flexibility. It’s not right for every association, but the associated advantages make it well worth consideration.

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What is ISO 13485 Manual and Its Requirements for Medical Device Manufactures

Quality is a degree to which a set of inherent characteristics fulfills requirements. The term quality is also defined as a totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. Similarly, quality manual defines the scope of the quality management system, including details of and justification for any exclusion. ISO 13485 Quality Manual references the procedures detailing the actual means by which the system operates and demonstrates the interaction between the processes which make up the system. Changes to the Quality manual that effect conformity to ISO 13485 or Regulatory requirements are submitted to the Registrar used by Systems.

The Quality Management Systems described in ISO 13485 Manual is specific to non-sterile and non-implantable medical devices components. Quality manual provides reference to the procedures established for the Quality Management System and also shows the relationship between the procedures and the requirements of the Quality Management Standards.  Measurable quality objectives are established at the appropriate functions throughout the organization that are relevant in supporting the quality policy, meeting the requirements for products and processes, improving quality and performance, and maintaining and enhancing customer satisfaction.

The quality management system for medical device manufactures is carried out in order to meet the requirements given in the quality manual as well as the quality objectives, and that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Including, those needed to meet requirements for the product, are established for relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy and include the planning of product realization to include the quality objectives and requirements for relevant the product.

ISO 13485 Audit Checklist and Its Requirements for Certification

Across the world, medical equipment manufactures and their suppliers are required to meet the highest quality assurance standards and regulations such as ISO 13485. Established by the International Organization for Standardization (ISO), ISO 13485 is the worldwide legal standard for organizations the design and manufacture medical products, equipment and parts. Compliance with this important standard is confirmed through a complex auditing and certification process. While meeting the many requirements contained in ISO 13485 is challenging, an ISO 13485 audit checklist can greatly simplify the process.

ISO 13485 Audit Checklist for organizations that need to assess and control of Quality Management Systems based on the international standard ISO 13485-2003 policy and procedure requirements. This audit checklist covers every standard requirement, and includes sample audits, mark sheet for the rating of the results. A team of experienced Manufacturing and Quality Engineers effort with input and suggestions with this set of audit checklist that is easy to use and time and error saving tool for every Medical Device Organization.

The audit checklist addresses all main and sub clauses and requirements of the ISO 13485 -2003 Standard. A simple rating system is included that enables the user to record compliance measurement based on the audit findings. The Set of ISO 13485 Audit Checklist and Guide contains Introduction Description how to apply and use the audit checklist, Short introduction into audit requirements, discerning minor verses major or critical nonconformities, and how to tally respective findings and rate the overall performance. The set of ISO 13485 Audit Checklist with questions addressing each requirement stated in the Standard contains all the documentation.

Medical manufacturer Device to plan and carry out regular internal audits, for this purpose ISO 13485 audit checklists is required, which is essentially a list of tasks that must be completed during implementation. The ISO 13485 audit is an integral part of the evaluation process for the internal audit plan. The format of this checklist encourages the auditor to objective evidence on the basis of the document: the processes of the organization, the characteristics of the process and the requirements of the audit standard. Typically, the lead auditor creates and manages the ISO 13485 audit checklist.

ISO 13485 Document Procedures

ISO 13485 is often compared to ISO 9001 and is a type of quality standard. It is an international standard that has to do with the quality management system for medical devices. This is a standard that meets the requirements of the regulatory effect and ensure that medical devices are manufactured in a correct manner and are out of good quality.

ISO 13485:2003 specifies requirements of 15 additional documented ISO 13485 procedures as listed bellow for use in the planning, operation, control and monitoring:

• Procedures for Maintaining facilities and equipment that affect the quality of medical devices.
• Procedure for Managing risk in the realization of medical devices (including their distribution, installation and servicing).
• Procedure for Designing and developing medical devices and associated installation, maintenance and disposal or recycling information.
• Procedure for Purchasing goods and services for the design, manufacture and distribution of medical devices.
• Procedure for validating the use of computer software.
• Procedure for validating sterilization processes.
• Procedure for Identifying and controlling medical devices according to their status.
• Procedure for maintaining the traceability of medical devices and their components.
• Procedure for Preserving medical devices and constituent parts.
• Procedure for controlling products requiring special storage conditions.
• Procedure for Using and calibrating monitoring and measuring equipment for manufacture, installation, use and servicing of medical devices.
• Procedure for Gathering and using medical device customer feedback.
• Procedure for Inspecting and testing medical devices and their components.
• Procedure for Determining, collecting and analyzing medical device QMS data.
• Procedure for Issuing and implementing Advisory Notices.