From Launch to Lifecycle, RCA can support your Design History File

We offer expertise in helping you navigate through new product development and remediating legacy Design History File (DHF) files 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 design history requirements for U.S. and international medical device industries to ensure regulatory compliance and drive business best practices.

In addition to design history file 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 Regulations (MDR) 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)

To begin the Regulatory Compliance Associates^® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.