regulatory and quality system professionals | 919.313.3960
Transitioning to ISO 13485:2016

Transitioning to ISO 13485:2016

In the event that you have not heard, ISO 13485 has undergone a major revision. As a quick recap, ISO 13485:2003 was overhauled by the technical committees in order to align more closely with regulatory requirements. The new version introduces a risk-based approach. This doesn’t mean that the traditional process approach has gone away, it means that risk management and risk analysis are going to play a greater role in how companies manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system. Read The New ISO 13485:2016 – Procrastination Can Cost You to learn more about the differences between the versions. What’s the Time Line for Transitioning to ISO 13485:2016? Ultimately, ISO 13485:2016 will replace ISO 13485:2003; however, over the course of the next three years (March 2016-2019), the standards will coexist. This will give manufacturers, notified bodies and regulators time to transition to the new standard. According to a transition planning guidance by ISO, organizations will be accredited for either edition for the first two years of the transition period. After the second year, new accreditation will only be given for ISO 13485:2016. After year three, any existing certification for ISO 13485:2003 will no longer be valid. In reality, this does not give you time to procrastinate. When you see the level of requirements you will have to account for, you will realize that taking necessary action should be a top concern. Preparing for the ISO 13485:2016 Transition Process Step 1: identify resources necessary to help implement the new standard Identify what will be needed (e.g. document review, gap...
How to Structure a New Medical Device Business

How to Structure a New Medical Device Business

There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation. Having a clear IP position and strategy is an important factor for attracting capital, which could further emphasize the importance of R&D, product development and market analysis. Nevertheless, being and growing as a viable medical device business catering to the U.S. market requires much more than R&D, positioning your IP and measuring how big your market is. It involves developing an operational framework that structures your organization as a medical device company (Figure 1) and enables the commercialization of your product. Some Medical Device Business Requirements: Regulatory Affairs Risk Assessment and Risk Management found in FDA Guidances and ISO 14971 Compliance to IEC 62304 to manage software risks Quality Management Design Controls that are included in FDA 21 CFR Part 820 QMS requirements you might find in Part 820 and ISO 13485 FDA 21 CFR Part 11, if your device incorporates software Safety Complying with IEC 60601-1 3rd Edition and its collateral standards Clinical data or a clinical trial When wrestling with regulatory, quality and safety issues, executives fresh to the medical device industry often take uncertain or delayed steps as they navigate the path to becoming a medical device company. The biggest mistakes we see emerging medical device business executives make include delaying the development of their regulatory strategy and their quality system, which...