Some changes currently shaping the global regulatory environment include: The Medical Device Single Audit Program—just one element of the global harmonization effort A transition to the new Medical Device Regulations for Medical Devices and IVD devices ISO 13485:2016—the latest version of this key medical device quality management system standard The revision of ISO 14971—a key risk management standard for medical devices. The first draft document for the revision should be out later this year. New guidance documents for complex medical devices and manufacturing processes, such as: Software as a Medical Device Technical Considerations for Additive Manufactured Devices Manufacturers Sharing Patient-Specific Information with Patients Upon Request Deciding When to Submit a 510(k) for Software Changes to an Existing Device Regulatory changes have become an inevitable part of medtech product development in recent years due to growth in complex devices and advanced manufacturing processes, as well as the ability to more efficiently generate, collect, and analyze data. Lean manufacturing and Six Sigma methodologies have affected compliance, too. During my tenure as a medtech employee and consultant, Lean and compliance responsibilities were often at odds within design and manufacturing operations. But now Lean and Six Sigma concepts are more accepted within the regulatory function.

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• HighTech / Internet / AI

• Compliance

• MPO

• 9/1/2018

• Abstract