visual resource

Design History File Support Services Handout

From launch to lifecycle, RCA assists in ensuring device compliancy. We offer expertise in helping you navigate through new product development and remediating legacy Design History Files (DHFs) within the complex and evolving regulatory environment.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

Please complete the form to access the visual resource.

*=Required

Design History File Support Services Handout

Design History File Support Services Handout

From Launch to Lifecycle, RCA Assists in Ensuring Device Compliancy

We offer expertise in helping you navigate through new product development and remediating legacy Design History Files (DHFs) within the complex and evolving regulatory environment. From launching a new product to market in accelerated timeframes to updating the design information necessary to validate and maintain the device throughout its lifecycle, we have a thorough understanding of the specific requirements for U.S. and international medical device industries to ensure regulatory compliance and drive business best practices.

In addition to DHF content, development, and management, download our handout to view more of our DHF-related support services, including:

  • Quality System Regulation, 21 CFR Part 820
  • The Design Control requirements of the CGMPs, 21 CFR 820.30
  • Device Master Records (DMR) and Device History Record (DHR)
  • The EU’s Medical Device Directive including Technical File / Design Dossier
  • Risk management (ISO 14971) for medical devices including risk analysis, FMEA, risk evaluation, and risk controls through Corrective and Preventive Action (CAPA) plan and design control requirements
  • IEC 60601-1-11 (2010) including Programmable Electrical Medical Systems (PEMS) (Clause 14)
  • Total product life cycle (TPLC)

Interested in Learning More?

Contact Us