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Author: leoeisner

What Do You Need to Know About Remote Audits?

What Do You Need to Know About Remote Audits?

Are you falling behind on your internal audit or supplier audit plans due to COVID-19, other emergency situations, sickness, travel restrictions, time constraints?  It really doesn’t matter the reason why you can rely on external resources to support your audits

leoeisner May 29, 2020June 12, 2022 Auditing, COVID, May 2020, Remote Auditing Read more

InCompliance Annual Guide Articles

InCompliance Annual Guide Articles

As a Senior Contributor to InCompliance, many years I am asked to update my articles to be placed in the Annual Guide but rarely do 2 of my articles show up in the Guide in a year. This year 2

leoeisner March 1, 2020June 12, 2022 60601 Amendments, 60601-1, 60601-1 A2, 60601-1 Amendment 2, EU, InCompliance Magazine, Mar 2020, MDR, Medical Device Regulation Read more

MDCG March ’20 Meeting – Industry & Notified Bodies Provide Feedback

MDCG March ’20 Meeting – Industry & Notified Bodies Provide Feedback

The Medical Device Coordination Group (MDCG) is meeting on March 11 & 12th to hold a series of meetings. Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR

leoeisner March 1, 2020June 12, 2022 EU, EUDAMED, IMDRF, Mar 2020, MDCG, MDR, Medical Device Regulation Read more

Faces in Compliance

Faces in Compliance

As a Senior Contributor to InCompliance Magazine, I have been fortunate to been asked to be part of this special supplement where InCompliance Magazine is featuring people that have been involved in Medical Device Compliance and Standards Development for a

leoeisner February 26, 2020December 25, 2020 Feb 2020, InCompliance Magazine Read more

MDR / IVDR Designation 2019 Stats

MDR / IVDR  Designation 2019 Stats

EU Commission promised 20 Designations 12 Notified Bodies Designated to MDR (9) & IVDR (3*) *All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting. It depends on your perspective. 2 NB’s

leoeisner December 31, 2019June 12, 2022 Brexit, Dec 2019, EU, EU Commission, MDR, Medical Device Regulation, NANDO db, Notified Bodies Read more
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510(k) 60601 series 60601-1 60601-1 3rd ed. A1 AAMI AAMI ES60601-1 AAMI ES60601-1/C1 Active Implantable Medical Devices Directive AIMDD Amendment 1 ANSI/AAMI ES60601-1 CDRH CENELEC Collateral Standard EN60601 EN60601-1 ESCNews EU European Commission FDA FDA Guidance Health Canada Home Healthcare Environments Home Use Home Use Environment Home Use Med Dvcs IEC IEC60601-1 IEC 60601-1 IEC60601-1 3rd ed. IEC60601-1-11 ISO 14971 IVD IVDD MDD MDD Amendment Medical Medical Device Medical Device Directive Medical Device Industry Medical Device Regulatory Medical Devices Notified Body Risk Management

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