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.
