Medical Device Consultant, CE Mark, Gap analysis, regulatory consultant, iso 9000, medical devices, fda

GAP ANALYSIS RISK ANALYSIS DESIGN CONTROL FDA COMPLIANCE QUALITY AUDIT ASQ FDA INSPECTION REGULATORY CONSULTANT CGMP QUALITY CONSULTANT
GAP ANALYSIS RISK ANALYSIS DESIGN CONTROL FDA COMPLIANCE QUALITY AUDIT ASQ FDA INSPECTION REGULATORY CONSULTANT CGMP QUALITY CONSULTANT
GAP ANALYSIS RISK ANALYSIS DESIGN CONTROL FDA COMPLIANCE QUALITY AUDIT ASQ FDA INSPECTION REGULATORY CONSULTANT CGMP QUALITY CONSULTANT
GAP ANALYSIS RISK ANALYSIS DESIGN CONTROL FDA COMPLIANCE QUALITY AUDIT ASQ FDA INSPECTION REGULATORY CONSULTANT CGMP QUALITY CONSULTANT
GAP ANALYSIS RISK ANALYSIS DESIGN CONTROL FDA COMPLIANCE QUALITY AUDIT ASQ FDA INSPECTION REGULATORY CONSULTANT CGMP QUALITY CONSULTANT
GAP ANALYSIS RISK ANALYSIS DESIGN CONTROL FDA COMPLIANCE QUALITY AUDIT REGULATORY CONSULTANT ASQ FDA INSPECTION CGMP QUALITY CONSULTANT
GAP ANALYSIS RISK ANALYSIS DESIGN CONTROL FDA COMPLIANCE QUALITY AUDIT ASQ FDA INSPECTION REGULATORY CONSULTANT CGMP QUALITY CONSULTANT
GAP ANALYSIS RISK ANALYSIS DESIGN CONTROL FDA COMPLIANCE QUALITY AUDIT ASQ FDA INSPECTION REGULATORY CONSULTANT CGMP QUALITY CONSULTANT












About me …

Medical Device Consultant


Most importantly there is the man behind his work, whom you should also know. Business is business, but that doesn’t mean that it’s all business.

Medical Device Consultant

 My name is Michael Ben. I am married to a wonderful woman, Donica. Not only is she my partner in crime, but she also designed and manages my website. We have had two beautiful and active boys, Dmitri and Henrik. The rest of our children include seven cats: Banky, Jane, Trudy, Felicia, Randall, Dante, and Maxim (or just Max). We have so many cats because they choose us … or as my wife says, they choose me. She calls me The Cat Whisperer.

ISO 9000

 My outside interests include playing with my boys, hockey, fixing up things around my house, playing my bass, listening to music, and watching Holmes on Homes, Law and Order SVU, House, Mythbusters, and Smash Lab. We are avid Kevin Smith and 80’s movie fans (classics like Better Off Dead, Real Genius, and St. Elmo’s Fire).

CE Mark

 After years of living many places within and without the Great State of New York, including Buffalo, Fulton and Montgomery Counties, the Hudson Valley, Central New York, and Dallas, Texas, we have finally settled here in Flackville, a small hamlet between Lisbon and Canton, NY. We love small-town living and the peace and quiet it brings. We own a 100-year-old house with some nice acreage and some good room for a huge tomato garden.

FDA

 My Curriculum Vitae is available upon request, as are professional references and documentation of accreditation and education. Please contact me if you wish to obtain this information. As my CV is an exhaustive list of my education, accomplishments and experience, I believe this forum should be used offer a more informal summary of my professional background.

Regulatory Consultant

 Engineering Training

Medical Device Consultant

 I graduated from Rensselaer Polytechnic Institute in Troy, NY with a B.S. in Biomedical Engineering in 1997. Biomedical Engineering was my chosen major from the day I took my first class and I never changed my mind.

CGMP

 Medical/Nursing Training

FDA Audit

 I took a brief hiatus from the industry to attend nursing school at D’Youville College in Buffalo, NY and worked extensively in local hospitals alongside RN’s and Physicians. During that time I supplemented my engineering education by experiencing what it was like to be and/or work with the end-users of medical devices.

Medical Device Consultant

 Accreditation and Continuing Education

medical device

 I am accredited by the American Society for Quality as a Certified Biomedical Auditor. This is a specialized certification for quality professionals working in Medical Devices, pharmaceuticals, and biotechnology.

ISO 9000

Products

design control

 My portfolio includes a wide range of devices. Some examples are:

fda inspection

 - Biotechnology and Hematology products
- Regional Anesthesia Catheters and needles
- Automatic External Defibrillators
- IV Infusion devices

fda consultant

 Work Experience

medical device consultant

 I worked with firms ranging from two to one hundred employees. I have worked both in the trenches and behind the scenes, from building prototypes to validation planning. I have been both the customer and supplier of products and services. I have audited and been audited. I have faced FDA twice in one of the strictest regions under FDA’s jurisdiction. I have audited a contract manufacturer half a world away as well as those a half an hour away.

a ce mark

 A short list of my work experience includes:

medical device

 - Supplier Audits
- Internal Audits
- Risk Assessment and Risk Analysis (dFMEA, pFMEA, FTA, and FMECA)
- Design Control process and documentation
- Process, Design, Sterilization, and Cleaning Validation Programs
- Process Development
- Product Development
- Biocompatibility Testing
- Failure analysis
- Training of Production and Management

ISO 9000
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