Home     |     Our Team     |     News     |     Contact Us     |     Call: 508-231-8842

Guidance on IVDR Significant Changes

Guidance on IVDR Significant Changes

Medical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional...

The FDA and Medical Device Cybersecurity

The FDA and Medical Device Cybersecurity

With everything from cars to pacemakers now susceptible to cyberattack, questions about how safe our data is have come to the forefront. The Food and Drug Administration (FDA) is one of the organizations taking these concerns seriously, working to ensure that medical...

Are Your Policy And Procedures In Place To Be Recall Ready?

Are Your Policy And Procedures In Place To Be Recall Ready?

If you are a medical device manufacturer, it is crucial to have the necessary recall policies and procedures in place to handle a potential field action quickly and effectively. A product recall can be costly and damaging to a company's reputation, so it's essential...

EU to Delay Portions of the IVDR Rollout

The European Union had recently proposed doing what the medical device industry has been urging for years – delaying the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR) that is slated to replace the current In Vitro...

Medical Device Regulatory Changes in the Post-Brexit UK

Medical Device Regulatory Changes in the Post-Brexit UK

If you are currently selling, or planning to sell, medical devices in the United Kingdom, the clock is ticking for Class III, IIb, IIa, and I devices. As of January 1, 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has mandated that all...

Supply Chain Woes: COVID and Medical Device Manufacturing

Supply Chain Woes: COVID and Medical Device Manufacturing

The sobering image on the evening news of dozens of massive container ships waiting off the coast of California is all anyone needs to know about the state of the supply chain today. Nothing is moving. Medical device manufacturing is just one of the many industrial...