Louis Meessen: Steps and regulations to follow when releasing a medical device

19 September 2018


Regulatory

August 2018, Louis Meessen, Project Manager product innovation hi-tech. In my role as Project Manager in product innovation, I had to follow the procedures as we had defined in our Product Creation Procedur to fulfil regulations needed for a medical device release.

First thing to do was define the class of the device, which showed to be Class I following the FDA definition: FDA 860.3 Definitions: Class I device is not life supporting or life sustaining or preventing impairment of human health, no potential unreasonable risk of illness and injury. General controls are sufficient for safety and effectiveness assurance.

After we defined the class, we studied the ISO13485 definitions and regulations, which showed us that ISO9001 “needs” 6 required documented procedures, where ISO13485 “needs” 27 required documented procedures. Next to this, there are principal differences between ISO9001 (used in standard release) and ISO13485 (used in the release of medical devices). A principal difference is that ISO 9001 requires the organisation to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organisation demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.

In order to release a medical device while following the ISO13485 and FDA regulations this means:

  • Executing the promotion and awareness of regulatory requirements as a management responsibility
  • Having the proper controls in the work environment to ensure product safety
  • Focusing on risk management activities and design control activities during product development
  • Following specific requirements for the verification of the effectiveness of corrective and preventive actions
  • Following specific requirements for the inspection and traceability for implantable devices
  • Following specific requirements for the documentation and validation of processes for sterile medical devices

In other words, the documentation needs:

  • Documents with a more detailed description on how the design was made, under what circumstances the products are made and all the international regulatory documentation, like design history file
  • A detailed description on work environment, cleanliness and hygiene
  • The specifications for purchased goods and services
  • Operational work instructions and reference materials and measurements
  • A detailed description of the usage of software, with the proper validations
  • To show that products shall be identified throughout the realization process, and procedures must safeguard that returned products are separated from conforming products
  • A detailed description of procedures for preserving the conformity of product during internal processing and delivery
  • To show that the organisation monitors information that relates to meeting the customer’s requirements
  • Documents describing the concession process, under which customers can accept non-conforming products
  • To show that the organisation documents customer complaints and the reasons for not following corrective or preventive actions
  • To show that the effectiveness must be measured and documented, when preventive or corrective actions are taken

After defining all the procedures and regulations that we had to follow, we made an action list for the extension to medical device release:

  1. Competence matrix staff
  2. Risk management, not only product, also process FMEA
  3. Verification, validation against acceptance criteria in product specifications
  4. Design review with signatures, authorization
  5. Process validation (100% and type test via process validation)
  6. Procedures, work instructions documented IQ, OQ, PQ (Installation-, Operational-, Performance-Qualification)
  7. Work environment (ESD etc.)
  8. Non-conforming products identified and labelled
  9. Software validation
  10. Traceability
  11. Calibration, monitoring test equipment.

In practice this meant:

  • Creating more procedures and documentation templates
  • Explaining, training and educating people for the need of extra documentation
  • Upgrade the TPD Technical Product Documentation and follow formal release chain of the TPD
  • Changing some WoW (Way of Working) in operations
  • Changing the development mindset, into even more SixSigma and documentation minded work.
  • Implementing the requirement-based designing method, following Verification and Validation along the V-model: First Time Right approach
  • Still more IQ, OQ & PQ needed, also at suppliers, where we need to be in the lead as we have the responsibility
  • Showing more effort on supplier quality assurance and supplier relations.

To conclude, all these points were executed over a period of several months in order to formalize the medical device release. And keep in mind that we had to release a Class I device. Releasing Class II or Class III devices is an even more extended effort and challenging job, which can take up more than 1 year.


We want to thank Louis Meessen for sharing his experiences about a product release with us. If you have any comments on Louis’ story, or if you want to share your own story, please contact us via info@medicaldevicescommunity.com or +31(23)7548660