Business type
Consultancy, US Designated Representative

Areas of operation
All regions

Company description
WF Jackson Associates, Ltd., a key medical device and in-vitro device consulting company that has been in existence for over eleven years, has successfully formed a strong clientele base through “word-of-mouth” exposure, a direct result of extremely satisfied companies.

President, William (Bill) Jackson’s regulatory experience has “grown up” with the evolving regulations in both the U.S. and Europe. For example, in 1976 The Medical Device Amendments were passed to ensure safety and effectiveness of medical devices; including diagnostic products.¹ Jackson submitted his first 510(k) in 1978.

Also, Jackson assisted in writing the Active Implantable Medical Devices Directive (90/385/EEC) and the Medical Devices Directive (93/42/EEC). His experience includes submitting over 300 510(k)s and more than 60 Technical Files for the AIMD, MDD, and IVD.

Contact W.F. Jackson Associates, Ltd, for all your regulatory, clinical, and quality needs for any medical device or in-vitro diagnostic, whether they are for FDA approval, European, and/or other countries. Mr. Jackson can be reached via phone (all calls returned within a 24 hour timeframe), at +1-651-773-0002, fax at +1-651-770-6770, or email at wfjassocs@aol.com or camilletennis@comcast.com.

¹ Milestones in U.S. Food and Drug Law History - FDA Backgrounder, May 3, 1999.