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.