KRM Associates, LLC

Your Team of Seasoned US, Domestic and International

Regulatory Affairs/Quality Assurance Consultants

 

www.KRM-Associates.com

Ken Michael has been a successful founder and entrepreneur of four VC funded medical device and bio medical companies and has actively participated in all aspects of senior management for a number of large and small companies.

 

He has been a consultant for a number of medical & pharmaceutical firms and has experience with a wide range of technologies ranging from radiation therapy, to cardiovascular and ophthalmologic lasers, infusion pumps, respiratory monitoring products, IVD diagnostics: ( Bio-Site PMA for Congested Heart Failure,  IDE, PMA, and 510(k)  Atairigin  developing  Breast & Ovarian  CA product Diagnostics,   Neuro-muscular simulation devices for paraplegics to an array of sterile disposable products.

 

Ken has been active working with various FDA personnel  at the District and Center levels involving a variety of product submissions and compliance issues and providing input to legislative strategies.

Ken was appointed and served on a number of  committees  & task forces with the California Health Branch FDA and implemented a number of training programs for them.

 

He has served as Chairman of various professional RA/QA Discussion Groups that successfully assisted in developing training  with  and for  FDA from the LA District,  Pacific Region, and All the FDA  3  Centers located in Rockville, Maryland.

 

Internationally he has participated on numerous European and Asian programs related to Quality and Regulatory Issues.  He has worked with most of the Notified Bodies involved with ISO and CE marking of medical device products.

 

Dr. Michael was a founder and served nine years as President and Chairman of the Board for the Regulatory Affairs Professionals Society, (RAPS), and served as an officer and board member of AAMI (Association of Medical Instrumentation, and NEMA (National Electrical Manufacturing Association). OCRA (Orange County Regulatory Association), SDRAN (San Diego Regulatory Associate Network).  He has appeared on numerous ASQ programs as speaker and moderator.

 

Ken was appointed to the Homeland Security Task Force related to healthcare in 2002 at the recommendations from the FDA Commissioners office.

 

He has been a lecturer on the extension courses for business opportunities that include  quality and regulatory programs at UCSD,  UCI, and UCLA.  He has been guest lecturer at University of Michigan, Ohio Sate University Medical School  etc.He participated on the formation of the San Diego State University Masters Program for Regulatory Affairs.

Ken is a Pharmacist and a Pharm. D. by education. He holds an appointment as an Adjunct Professor at various medical centers on subjects relating to regulations & quality issues relative to the practice of medicine involved in product evaluations: e.g. informed consent responsibilities for investigators at the academic clinical medical centers, use , misuse of preparations dispensed to the terminally ill, (Bromptons Mixture),  IRB ethic considerations for emerging technologies. .

 

Ken is the holder  a number of personal and Corporate patents

 

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