Regulatory Compliance

Regulatory Compliance

Resolution complies with the process controls required under the Quality System Regulations of Section 21 of the Code of Federal Regulations Part 820 and International Organization for Standards 13485/2003. As a product development firm, Resolution creates elements for the Design History Files and Device Master Records following our clients’ or Resolution’s quality management system and standard operating procedures.

Resolution works closely with our clients to establish design and development plans to insure that the development program is in compliance throughout the product development life cycle.  By working closely with our clients, Resolution fosters a team environment that allows us to efficiently drive to and document decisions, generate customer and product requirements, and generate the required risk analysis, FMEAs, and Hazard Analysis required to develop and to launch safe and effective products into the Medical Device market.

Our regulatory compliance services include:

  • Design plans
  • Design inputs
  • Risk analyses (FMEA, HAZ)
  • Formal design reviews
  • Drawings and specifications
  • Verification and validation
  • Work instructions
  • Labeling
  • Change control
  • Design transfer