Each manufacturer of Medical devices (e.g. ECG machines, IV cannula, IV set etc.) and combination products ( Drug, device combination products like prefilled syringes, applicators of the tropical products) shall have adequate Design and Development activity done so as to prove the adequacy of the safety and efficacy of the product. The design and development activity is the systematic methodology, which establishes the proper design and development of the products. Many of the customer complaints and 483’s in case of the medical devices or combination devices are contributing to the improper of the design and development control activity. The design and development requirements of the product are described in ISO 13485: 2016 and 21 CFR Part 820 also.
The Pharmaceutical organization which manufacturers the combination products are expecting to implement the 21 CFR Part 210, 211 and Part 820 for their manufacturing sites of the combination products. At the end of the Design Phases, the DHF is compiling and shall present during the audits. The DMR shall extract from the DHF for the routine use and the tech transfer. The requirements mentioned in the DMR shall use to create the DHR to demonstrate the routine production and compliances. As per requirements of the ISO 13485:2016, the medical device file shall be established. The complexity of the design procedure is dependent on the Product complexity and intended use.
The design control is the vital part as far the Quality Management System goes.
Each manufacturer of a medical device shall establish and maintain procedures to:
- Control the design of the device
- Ensure that specified design requirements are met
To ensure that devices meet
- Users’ needs and intended uses
- Requirements and Specifications
- Regulatory requirements
- Can be reproducibly and reliably manufactured, serviced and/or installed.
Tools for archiving purpose
- Establish design control procedures
- Develop plans for Design Projects(Include interfaces between R&D and other units)
- Identify design inputs requirements and high-level specifications for the device
- Develop design outputs (to final specifications)
- Design Verification through measurement, analysis, test or inspection that all design outputs fulfil input requirements.
- Transfer outputs to production
- Design Validation that the device performs and functions as intended and as users need an expect.
- Control changes during design and development and to existing devices Document design activities in design history file.