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.

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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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.

Process for Achieving ISO 13485 Certification

ISO 13485 is predicated on the ISO 9000 family of “quality” standard; it's a set of this broader standard specifically targeted on the planning, development and producing of medical devices. The particular full title of the quality is Medical devices– Quality management systems– necessities for restrictive functions.

As this name implies, 13485 provides an outline of what should be enclosed within the Quality Management System (QMS) of a medical device manufacturer. Within the case of patient management software package publishers, the iso 13485 standard would apply to the software package development processes that these firms undertake to make their merchandise.

What is the process for achieving ISO 13485 certification?

1.       Verify the gaps between your current operative procedures and people necessary to pass the ISO 13485 audit.

2.    Shut the gaps; build the changes necessary to bring your operative procedures in line with what's required. Typically, this can involve making iso 13485 documentation for procedures wherever there don't seem to be, today, formal workflows. it's conjointly needed, as a part of the audit, that the organization is ready to demonstrate that team members:

• Are aware that there square measure standardized operative procedures
• Know what they are; and
• Know wherever to seek out the acceptable documentation. Often, this suggests there'll be a desire for education and/or coaching.

3.   Once your modification management method is finished, do a pre -audit to insure that you simply are successful once the auditor comes. Repeat step a pair of to deal with any gaps that also exist.

4.      Be formally audited by a Health North American nation recognized auditor