How to manage the design and development of medical devices according to ISO 13485:2016

The design and development process management standard ISO 13485:2016 introduces several new specifications to design and development, including design files and transfer records. The conditions for design and development are as follows:

1) Method - The organization must define roles for various tasks, such as assigning approval authorities, and document all the logical design and development phases in a well-structured procedure.

2) Planning - The most crucial stage of design and development is planning because careful planning can avoid needless delays. During the planning stage, the organization should define the goals and objectives for the product's design and development, the breakdown of crucial activities, including risk management activities, the timeline for the project as a whole, and the resource allocation required for each design and development phase.

3) Inputs - As is often the case, "trash in, garbage out," therefore the caliber of design and development inputs is essential for generating the desired results. The following should be included by the organization as inputs:

• Application in mind
• Usability specifications, such as those for its use, preservation, handling, and maintenance
• needs for clients and end users
• physical characteristics, qualities, and manufacturability
• Occupational safety and ergonomics
• Techniques for risk reduction and control
• Past grievances, failure reports, and negative incidents involving comparable products
• necessary statutory, legal, and regulatory requirements as well as reasonable norms
• Needs for maintenance and sterilization
• Economic analysis and cost-benefit analysis

4) Results - The company can generate design results in the following ways:

• Drawing standards for raw materials, component parts, sub-assemblies, and final devices
• The production process and environmental requirements
• A quality assurance procedure that outlines the acceptance requirements
• Procedures for product identification, tracing, production, packing, and inspection
• documentation needed to submit devices to regulatory agencies for marketing
• Design history record to show that the design was examined and approved

5) Review - The design review is a thorough stage that tackles several customer and manufacturing issues. For instance, the company must show whether the design satisfies the specifications for the product, whether it is compatible with processing power, whether safety concerns are addressed, whether it is environmentally friendly, and whether the materials, facilities, components, and service elements are sufficient. Design reviews are typically conducted in meetings, and minutes must be kept.

6)Verification- It is a necessary step in the verification process. It guarantees that design outputs conform to input specifications. Using tests (lab tests, chemical analysis, etc.), substitute calculations, comparisons of tested designs, inspections, and reviews of documents like specifications records, drawings, procedures, plans, reports, etc., the organization can validate designs.

7) Validation - A step after design verification is design validation. This stage ensures that the medical device complies with the needs of the application and the end user. Samples from lots that were initially produced are used for validation. The product is tested in simulated environments to validate its performance (e.g., clinical testing of medical devices). It is necessary to keep track of design validation records.

8) Transfer - A procedure for transferring design and development outputs to manufacturing must be documented by the organization. This is more than a simple transfer of design duties from the product development team to the manufacturing division. Instead, it indicates that the product development team has taken steps to ensure that the design can be implemented in production and that records of this transfer are kept.

9) Control of Changes - A mechanism for controlling design and development changes should be a part of the process of designing and developing medical devices. Based on the review, verification, validation, complaints, risk mitigation, manufacturing issues, etc., a design change may be required at any time. Changes should be reviewed, verified, validated, and approved in light of design inputs and requirements before being put into effect.

10) Design and Development Files - The company needs to keep a file for each medical device design it creates. The file may contain records of review, verification, validation, and changes, as well as reference records demonstrating conformity to design specifications.