Regulatory Affairs
Ken Block Consulting
Regulatory Requirements:
Regulatory Background:
Successful medical device companies have a comprehensive
understanding of regulatory requirements and proactive liaison with
FDA regulators. Specific documentation, record keeping, submissions
and assignments are required by the regulations that FDA enforces.
 | | Direct Interaction with FDA at All Levels
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| | Former Corporate Director, Regulatory Affairs
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| | U.S. & International Regulatory Experience
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| | RAPS Medical Device Session Leader |
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Regulatory Services Provided:
| | FDA Regulatory Compliance Strategy
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| | FDA Liaison (Compliance/Small Business/Field Office/etc.)
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| | Establishment Registrations (Initial/New/Modified/Annual)
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| | Device Classifications and Product Listings
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| | Premarketing Clearance 510(k) Submissions
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| | Product Pre-submission Conferences
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| | 510(k) Exemptions and Special Controls Requirements
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| | Assignment of FDA Official Correspondent
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| | FDA Biocompatibility Requirements
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| | Mock FDA Inspections
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| | FDA Industry Meetings
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| | FDA Inspection Observation (Form 483) Responses & Activities
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| | FDA Warning Letter Responses & Activities
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| | International Import/Export Issues
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| | CE Marking
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| | Certificates to Foreign Government
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| | On-site FDA Visits & Investigations
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| | Labeling Specification & Review
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| | Marketing Materials Review (Websites/Inserts/Press Releases/etc.)
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| | FDA Initial Product Reports (Laser Devices)
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| | Laser Testing & Classification (FDA + IEC 60825-1 + AS/NZ 2211)
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| | U.S. Agent for Foreign Medical Device Companies |
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Kenneth L. Block, RAC* - FDA & ISO Services to Medical Device Companies Worldwide
Contact Information:
*Certification:
Kenneth L. Block has earned the Regulatory
Affairs Certification (U.S.) from the Regulatory
Affairs Professionals Society (RAPS). The RAC
(U.S.) is earned through professional examination,
regarding comprehensive knowledge of FDA and
related U.S. regulations, policies and guidelines in
the areas of medical devices, drugs and biologics.
The RAC (U.S.) designation is a mark of distinction
for regulatory professionals dealing with FDA
products and issues including strategic planning,
design & development, pre-market & regulatory
review, manufacturing quality systems, marketing,
post-approval and FDA interfacing.
Ken Block Consulting
1201 Richardson Drive
Suite 140
Richardson, TX 75080 | |
© 2007 Ken Block Consulting
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