Welcome 3 Global Experts to the Eisner Safety Consultants Team

Welcome 3 Global Experts to the Eisner Safety Consultants Team

We are thrilled to announce three incredibly talented individuals joining the Eisner Safety Consultants Team to support your needs.

Beat Keller’s expertise comprises the IEC 60601 series, software, and regulatory/quality. In the regulatory/quality area his focus is on EU MDR, Swiss MedDO and UK MDR.

Lisa Donlon’s expertise encompasses device regulatory/submissions and quality. Her focus is on EU MDR, clinical support, and the U.S.

Dan Modi’s expertise spans the IEC 60601 Series, EMC, design quality, device submissions/regulatory – EU MDR, U.S., India, China, Brazil, Japan and more.

We have strengthened our team to support your needs so please feel free to schedule a meeting to discuss your needs or contact us.

What’s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

What’s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

What’s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

💥𝗕𝗥𝗘𝗔𝗞𝗜𝗡𝗚 𝗡𝗘𝗪𝗦💥 𝗜𝗠𝗗𝗥𝗙 𝗡𝟰𝟳 & 𝗡𝟱𝟮 recently updated to 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟮 – 𝗪𝗵𝗮𝘁’𝘀 𝘁𝗵𝗲 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽 𝘁𝗼 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝟰𝘁𝗵 𝗲𝗱❓

IMDRF N47 & N52 both have been updated which will support Regulatory Submissions and Compliance Testing for the future of the IEC 60601 series including IEC 60601-1, 4th edition.

𝗜𝗠𝗗𝗥𝗙 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 two Final documents on 𝟮𝟲 𝗔𝗽𝗿𝗶𝗹 𝟮𝟬𝟮𝟰, both to Version 2:
N47 Essential Principles of Safety and Performance of Medical Devices & IVD Medical Devices, and N52 Principles of Labeling for Medical Devices and IVD Medical Devices

Standards: Explosion and Challenges Maintaining/Updating

Standards: Explosion and Challenges Maintaining/Updating

Standards: Explosion and Challenges Maintaining/Updating

 My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.

FDA’s ASCA Program Becomes Permanent

FDA’s ASCA Program Becomes Permanent

Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments

FDA Recognizes IEC 60601-1 Edition 3.2

FDA Recognizes IEC 60601-1 Edition 3.2

On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List