Since medical devices directly affect the human body, safety is more important than non-medical industrial products. Each country has established standards and regulations to ensure the health and safety of people, and manufacturers of medical devices have to fulfil all these in order to get their product to the market. This is not an easy process. Especially start-ups are struggling with preparing the necessary documents and comply with all requirements.
For 3D printed implantable devices, a relatively new technology, it proves specifically challenging to identify the necessary standards and procedures. We therefore have identified 5 key steps to help you on the way to get your quality management system set-up.
Please note, these are the standards and steps we found necessary when we were developing our implant, dependent on the materials in the product, intended use or geography (and many other aspects) different standards might apply.
Step 1: Define the applicable regulations and standards
Start with a complete research on the applicable standards and regulations. Besides the QMS ISO13485 standards for the CE markets (e.g. Europe) and 21 CFR PART 820 for FDA markets (USA), you need to identify the relevant ISO, ASTM, MDCG and other standards or guidelines for the following parts in of your product and company:
- Risk management
- Performance and safety for implants
- MR test for implants
- Clinical evaluation
In our white paper you can find a suggested list of standards per topic.
Step 2: Set up a solid quality management system.
The quality management system covers the complete lifecycle of a medical device from initial conception to the final disposal. Your quality management system should at least entail the following:
- Design the manufacturing flow
- Set-up quality documentation
- Verify the process
- Validate the process
Step 3: Keep track of each step of manufacturing with documentation
According to the documented production procedures and process work instructions, a product should be manufactured, processed and inspected. Manufacturing evidence should be recorded and maintained under the QMS. The manufacturing records should be traceable from raw materials to shipping to customers, in the so-called Device History Records. To trace a medical device the UDI system has been introduced, which should be included on the packaging and implant cards for patients and enables this traceability.
Step 4: Don’t forget maintenance and monitoring
A company should conduct maintenance on equipment periodically and monitor processes including the manufacturing processes and the product under a quality management system. You have to record these maintenance activities and monitor the results as evidence of these activities.
Step 5: Have regulatory intelligence integrated into your system
Regulatory intelligence is the activity of keeping up with updates in regulations applicable for your device. The monitoring, gathering and analyzing of publicly available and experience-based regulatory information is key to develop a strategy for medical device development. Regulatory monitoring fits into the overall monitoring system.
When developing 3D printed implantable devices, it is suggested to follow these five main steps in order to prepare for regulatory requirements based on the FDA and CE regulations. To give you some examples and a more detailed description of the applicable standards, we have developed a white paper that can be downloaded here.
Let us know your experience with implementing your QMS and good luck!