Services Overview

“Regulatory Affairs” encompass the activities required to ensure the legal compliance of medical device companies. These activities establish and maintain the structure necessary to legally market a device. Ken Block Consulting specializes in regulatory affairs related to medical devices and medical device companies.

Regulatory Requirements:

Successful medical device companies have a comprehensive understanding of regulatory requirements. Specific documentation, record keeping, submissions, and assignments are required by the United States Food and Drug Administration (FDA) regulations.

Ken Block Consulting has a high level of expertise in FDA regulatory compliance, in both detailed knowledge of requirements and implementation of compliance mechanisms. We also have direct experience interacting with FDA personnel during inspections, submission reviews, and meetings.

Regulatory Services Provided:

Ken Block Consulting offers a variety of services to address the needs of medical device inventors and companies, both those that are new to FDA regulations and those that have established regulatory affairs departments in need of additional assistance.

Listed in the expandable menus on this page are examples of services that we have provided to clients. These have been organized into categories, but some services may be applicable to more than one category. If a specific service you are seeking is not listed, please contact us directly at or through the form under the Contact section of this site.

Regulatory Compliance   +

  • FDA Regulatory Compliance Strategy
  • FDA Liaison (Compliance/Small Business/Field Office/etc.)
  • Establishment Registrations (Initial/New/Modified/Annual)
  • Device Classifications and Product Listings
  • Assignment of FDA Official Correspondent for Foreign Medical Device Companies
  • International Import/Export Issues
  • Certificates to Foreign Government
  • On-Site FDA Visits and Investigations
  • US Agent for Foreign Medical Device Companies
  • QMS Gap Audits and Mock FDA Inspections
  • Comprehensive, On-Site Training

Regulatory Strategy and Submissions   +

  • Premarketing Clearance 510(k) Submissions
  • Product Pre-Submission Conferences / Meetings
  • Device Classifications
  • 510(k) Exemptions and Special Controls Requirements
  • FDA Biocompatibility Requirements
  • EU Technical Files
  • FDA Initial Product Reports (Laser Devices)
  • Laser Testing and Classification (FDA + IEC 60825-1 + AS/NZ 2211)

Interaction with FDA   +

  • On-Site FDA Visits and Investigations
  • FDA Inspection Observation (Form 483) Responses and Activities
  • FDA Warning Letter Responses and Activities
  • FDA Industry Meetings and Other Public Meetings

Marketing and Labeling   +

  • CE Marking
  • Labeling Specification and Review
  • Marketing Materials Review (Websites, Inserts, Press Releases, etc.)