Things to remember when scaling your Design History Files (DHF):
- One size does not fit all
- All classes of devices need design controls
- The process is scaled based on the complexity of the device and the size of the company
- Don’t wait for the regulators to identify any gaps
When you scale your Design Controls appropriately to the complexity and size of your company, it makes it easier to manage the scope of everyday work needed to keep your files current.
Also, identifying your gaps up front, closing them upon identification, then wrapping them into your entire DHF process with your team or with a third-party consultant like RCA helps ensure you have a rock-solid DHF and that you will be prepared when the regulators ask questions.
Listen to the full DHF & Design Control episode Here!
DHF Support – From Launch to Lifecycle, RCA Assists in Ensuring Device Design History
We offer expertise in helping you navigate through new product development and remediating legacy Design History Files (DHF) 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 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 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)
Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.