21 cfr design controls Archives - Regulatory Compliance Associates

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From digital health to surgical robotics, BIOMEDevice is the starting point for the discovery of progressive solutions to challenges and impactful products. We bring together engineers, business leaders, disruptive companies and innovative thinkers from the top start-ups and medical device OEMs together to inspire and collaborate on the next lifechanging medical device. Our community comes together in Silicon Valley the #1 MedTech hub in the country to share new innovations, educate each other on what’s new in the industry, collaborate on new ideas, and partner to move the industry forward.

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.

Click to listen to RCA’s full DHF & Design Control podcast Here!

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

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Tag: 21 cfr design controls

About BIOMEDevice Silicon Valley

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

Click to listen to RCA’s full DHF & Design Control podcast Here!

FDA Design Control

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.

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

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.