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Preparing for commercialization is an exciting time for an organization. After months, often years, of development and regulatory work, you now have your regulatory authorization in hand and are ready to sell your product. In addition to building up sales and marketing efforts, however, you will need to ensure your quality management system (QMS) is launch-ready. Before you can ship your first product, there are a few pieces of your QMS that need to be in place to continue to be in compliance and ultimately ensure a successful launch.
Here we outline five must-haves for your QMS as your organization prepares for commercialization:
- Post market surveillance
- Customer inquiry and complaint handling
- Technical support procedures
- Recall plan
- Internal audit plan
Let’s dive deeper into each one.
1) Post-market surveillance
Medical device companies must continue to monitor their product for safety and effectiveness after it is released into the market. When a product is adopted widely and used on larger populations, unexpected events may occur that were not observed during any premarket evaluation/studies. Things like adverse events, complaints, and recalls can happen after a product is released into the market. To stay compliant with ISO 13485 and 21 CFR 820, your QMS must adopt procedures defining how the company will conduct post market surveillance
2) Customer inquiry and complaint handling
Related to post market surveillance, your company will need to have a process for customer inquiries and complaint handling. This process must be documented in your QMS. If and when complaints come in, you will need to investigate to determine if device safety and/or effectiveness is still being maintained. As mentioned above, this is also part of your post-market surveillance and also feeds into your risk management.
3) Technical support
A QMS must include a procedure that outlines how the company manages technical support inquiries from customers and/or end-users. Your procedures should cover how the company handles investigation, troubleshooting, testing, and follow-up on these inquiries.
4) Recall plan
While it doesn’t happen often, recalls of medical devices do happen and is to be taken very seriously. Your QMS should outline procedures around definition of a recall, initiation, strategy, implementation, and follow-up of a product recall.
5) Internal audit plan
An internal audit of your QMS is required to stay in compliance with ISO 13485. This audit can be done internally by a qualified internal audit team or by a certified external auditor. The goal is to periodically check that the company’s processes are being maintained and followed as intended. It’s important to include a procedure on how your company manages internal audits, which includes how they are performed, monitored, and how actions are taken based on the results.
Remember, your QMS will evolve as your organization and product evolve. Getting ready for commercialization is a major milestone and having a well prepared QMS will eliminate potential roadblocks as you go to market.
Need help with your QMS?
Did you receive regulatory authorization and could use some help with updating your QMS? Our Post-Market QMS Toolkit has all the standard operating procedures and accompanying forms needed to get your QMS in compliance with ISO 13485 and 21 CFR 820. We provide downloadable, customizable templates for all of the above must-haves that are simple and easy to incorporate into your QMS. Learn more about our QMS toolkits here.
