I am the founder and principal compliance and regulatory consultant of Eisner Safety Consultants, we provide the medical device industry with product safety compliance & regulatory support.

I ensure my clients’ medical device compliance needs are met with uncompromising attention to detail and quality. I provide my clients with practical assessments of their product(s) and provide strategies & support to help them through the medical device product compliance maze.

As an expert in the standards development process, I have been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417

1. Provided expertise to 100’s of SMEs and Fortune 500 companies for successful medical device compliance projects

2. Reviewed/generated 30+ product safety and labeling/marking sections of EU technical file/technical documentation (MDD/MDR) / DHF for active medical devices and active medical implantables

3. Expert Member of development teams on IEC 60601-1, edition 3.2 (via IEC TC62/SC 62A/MT28 & MT30 & WG14 & IEC TC62A/Ad Hoc Group 62368-60601) and 4th edition of IEC 60601-1 – Working Groups assignments in process currently – https://bit.ly/IEC60601-1FourthEdTimeToGetInvolvedIsNOW

From his LinkedIn:

I am a board-certified orthopedic surgeon and a consultant for medical devices. I combine 17 years of experience as a medical professional and 6 years working as a clinical reviewer for a European Notified Body to help medical device manufacturers bring their devices to the market. I am specialized in the regulatory requirements for clinical data for medical devices and the planning of pre- and post-market clinical investigations.

From his LinkedIn:

I am a highly experienced Orthopaedic Surgeon with advanced training in Medicine and Orthopaedics, including an International Arthroplasty Fellowship in Germany. My career spans diverse healthcare environments, from super-specialty tertiary centers in India to specialist roles in Dubai, and, more recently, in the UK, where I practice in the West Midlands. I currently serve as the Chief Medical Officer for Orthopedics and Spine at Eclevar, where I focus on regulatory strategy, clinical oversight, and advancing patient care.

I have led clinical research teams that produced significant publications and international conference presentations, contributing to advancements in orthopaedic care. My leadership in quality improvement and clinical governance has helped optimize patient care pathways in alignment with national standards.

In addition to my clinical and research experience, I am committed to education and training. I have authored journal articles, contributed to textbooks and digital resources, and continue to mentor the next generation of surgeons and healthcare professionals.

Passionate about revolutionizing quality management, she founded BushmanQC Virtual QMS, LLC to empower organizations to streamline their quality processes in the digital age.

With a keen focus on efficiency, compliance, and customer satisfaction, she lead a team dedicated to delivering cutting-edge virtual Quality Management System (QMS) solutions tailored to each client’s unique needs.

BushmanQC Virtual QMS mission is to elevate quality standards across industries, harnessing technology to drive continuous improvement and excellence.

Randy is the President of US Inventor, an organization working to restore the American Patent System. The future of American innovation depends on the ability of the independent inventor to defend his or her patent rights, no matter how disruptive the invention. Randy is also an inventor and President of Complete Product Development, a company that provides CAD design, prototyping, 3D printing, silicone molding and educational services to inventors and companies.

Nic is a medical technology consultant in health economics, payer perspective, reimbursement and market access. After finishing school in Boston, he began his career as a Payer determining which medical technologies were paid for by Intermountain Healthcare and was a member of Intermountain’s New Device and Technology Committee (Value Analysis). He left this role after seven years to start and eventually take public a biotech company in the tissue regeneration space where he served as the Director of Market Access. He is presently in health economics and market access at a major medical device manufacturer. He is a consultant to Venture Capitalists and start-ups who are working on new life science products, helping them identify what health insurance companies and hospitals want in a technology and for what they’re willing to pay. He is a Strategic Advisor to medical technology companies and is a guest lecturer at UCSF School of Medicine, University of Utah and at conferences and symposiums around the world where he speaks on clinical trials, HEOR, commercialization and reimbursement. In February 2017 Nic was the Expert in Residence at the Dubai 100, a digital health accelerator located in Dubai.

Nic’s experience in life sciences spans devices, diagnostics, biotech and digital health. Companies turn to him to understand what trials and health economics will be necessary to obtain market access and reimbursement.

On the personal front, he lives in Utah with his wife and kids and is a cyclist, skier and a forever student of the Austrian School of Economics.

Education:
BA, Behavioral Neuroscience. Purdue University
MA, Biomedical Imaging. Boston University School of Medicine
MBA, Business Administration. University of Utah

Jan Gates has 35+ experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements. Her work includes production optimization, validation, and minimal packaging for sustainability. She has previously worked for Bristol Myers Squib, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as an independent consultant in her company, PackWise Consulting. Jan works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing. She is also working as a US representative on various ISO TC 122 committee for packaging testing, vocabulary, labeling, and product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices); the guidance document was converted to ISO/TS 16775. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board and IoPP Medical Device Packaging Technical Committee member.