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. 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
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.
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FDA Design Control
RCA offers medical device consultants who will help you navigate through new product development and remediating legacy Design History Files (DHF). Our life science consultants have a thorough understanding of the specific design history requirements for U.S. and international medical device industries. We’ll support your team’s ability to ensure regulatory compliance and accelerate medical device DHF best practices.
In addition to DHF content, development, and management, download our handout to view more of our DHF-related support services, including:
- FDA design control requirements
- Quality System Regulation, 21 CFR Part 820
- Design control medical device CGMPs and 21 CFR 820.30
- Device Master Records (DMR)
- Device History Record (DHR)
- ISO 13485 design control
- Design control procedures
- Design control process evaluation
- Design control documents
- Design quality control
- 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)
- AAMI design control
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 regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.