Dedicated to design & manufacturing for medical device
20-22 December 2021 | SWEECC H1&H2
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Policies & Regulations
2021.09.13 Changing Medical Device Regulations in the United Kingdom and in Europe A look at how medical device companies can meet the need for a UK Responsible Person...... Read More
2021.08.05 Mitigating Risk Through Quality Management in Medical Device Manufacturing Consider these 4 steps when developing a quality management strategy....... Read More
2021.07.27 Secure by Design: Developing Cybersecure Medical Devices As software-based medical devices become increasingly connected, cybersecurity must be considered right from the first design stages in order to protect patients’ health and personal data. However, in many instances there are no standards or clear guidelines for the medical sector...... Read More
2021.06.21 An Ingredient List for Your Medical Device? FDA seeks feedback on medical device content labeling...... Read More
2021.05.19 One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the new medical device regulation (EU MDR), according to a recent survey. These results come one year after the regulation’s postponement and a few weeks before the new validity date...... Read More
2021.04.28 Chemical Compliance Requirements for EU MDR and IVDR Is your medical device or diagnostic in compliance with this small, but essential, sub-section?...... Read More
2021.04.21 What Are the Biggest Changes under EU MDR? With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements...... Read More
2021.04.19 Companies, docs alarmed by proposed 510(k) rollback Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process...... Read More
2021.03.26 European regulators publish new Q&A on custom-made medical devices The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance...... Read More
2021.03.17 Why Risk-Based Thinking Is Essential in Medical Device Development Many global regulatory requirements now include risk management, so medtech companies may need to revisit their quality system processes...... Read More