Design Control

Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process. We help you establish compliant design control processes under ISO 13485 and 21 CFR 820.

Our support includes:

  • Design and Development Planning
  • Design Inputs and Outputs
  • Design Verification and Validation
  • Design Transfer and Changes
  • Design History File (DHF) compilation
Contact Us for Support
Design Control Under EN ISO 13485 & 21 CFR PART 820

Related Services

Application of Risk Management to Medical Devices

Integration of a risk management system into your existing quality management system.

+ Learn More

MDSAP Program

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a …

+ Learn More

The New EU Medical Device Regulation (MDR)

Comprehensive guidance on EU MDR compliance requirements for medical device manufacturers.

+ Learn More

Contact Us

We typically reply within a few hours

👋 Hi there! How can we help you today?

Fill out the form below and we'll get back to you as soon as possible.