USDeviceAgent.com was founded by Jim MacNee in response to the ever changing regulatory environment. Since the late 1980's when he joined Allied Healthcare Products, Inc. (AHPI) as Vice President, Jim has been involved in the international medical device field. As part of the senior management team he grew the business from $48MM to almost $120MM and in the process, took the Company public. In recognition of his past and potential contributions to the organization, Allied's Board of Directors appointed Jim as General Manager for AHPI's newly acquired entity: Bear Medical Systems, Inc.

It was, in part, Jim's ability to recruit and retain a superb staff that allowed Allied, in less than three years, to sell a business that had been purchased for less than $20MM for over $36MM. Jim left the business shortly after it was acquired by the Thermo Respiratory Group (now Viasys Healthcare) and took a short term assignment as President of a plastics company in the San Fernando Valley which had just been acquired by Summa Industries (SUMX).

in 1999 Jim chose to leave the corporate fold to bring his expertise in medical device matters to a multitude of organizations. Over the past several years Jim has worked for clients ranging from small companies with as few as two employees to industrial entities with hundreds of employees.

Jim holds a BA in Psychology from Albion College and a Masters in Management from Washington University in St. Louis. To keep his skills sharp, he teaches graduate courses in Organizational Development for the University of Phoenix Online.

Stan Fry, JD
Principal Consultant

Stan Fry brings over 25 years of diversified experience to the team. His expertise includes Regulatory Affairs, Quality Assurance, Engineering, and Product Safety Analyses. His engineering background is particularly beneficial in Design Control issues. He is also an attorney at law.

Stan has served at the Vice President level in significant corporations with world wide activity. He has worked with FDA and regulatory issues since the outset of the Medical Device Amendments in 1976. The following offers some highlights of Stan's extensive experience:

o FDA filings including, 510(k)'s, IDE's, PMA's covering a wide    variety of devices including life support equipment, disposable    devices and diagnostic laboratory supplies.

o Administered various conflicts with FDA including resolution of    inspection issues, 510(k) issues and more serious matters up to    and including seizure actions.

o Set up and administered IDE's including interface with clinicians    and related agreements and related clinical investigations.

o Established QSR system and procedures including Design    Controls.

o Administered numerous FDA inspections and resolved FDA    483 items aggressively.

o Product Safety analyses for proactive product review.

o Complaint/MDR administration.

o CE marking and European MDD compliance systems

o EO and Gamma sterilization, including validation per ANSI and    EU standards

o Reliability testing programs.

o Validation and Verification procedures per Design Controls    requirements.

o Root cause failure analyses programs.

o Quality systems and Quality Manual per ISO 9000.

o Set up systems in compliance with EN9001/46001/ISO 13485

o Risk analyses including hazards analyses and FMEA per    EN1441.

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