Dedicated to design & manufacturing for medical device
1-3 September 2021 | SWEECC H2&H4
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Policies & Regulations
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
2021.02.03 FDA says to limit mask decontamination to 4 cycles Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times...... Read More
2021.01.08 Traceability Requirements in EU MDR Medical device manufacturers marketing products in the EU must ensure traceability between all stages of medical device development and post-market activities....... Read More
2020.11.26 Can Design Controls Accelerate Medical Innovation? Response to the pandemic fast-tracked the pace of medtech innovation. In the future, can a human-centered iterative approach to design controls help maintain that momentum?...... Read More
2020.11.24 The Critical Importance of Patent Protection for Diagnostics in the COVID-19 Era Court cases have established the means for determining the patent eligibility of diagnostic methods. Does your diagnostic pass the test?...... Read More
2020.11.19 How does HIPAA affect medical devices? Medical device manufacturers need to understand patient privacy law and how to comply with it....... Read More