A team of SMEs to support your Design Control Activites

Medical Device & Combination Products

DESIGN CONTROL IS A REGULATORY REQUIREMENT

Regulatory Requirements

  • Yes, there are regulatory requirements around Change Control.
  • No, you can’t get around them.
  • Yes, they are getting tighter.

As described in FDA Guidance document: “DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS

Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances.

What is Design Control?
 Establishment of an intended use and design inputs
 A design plan
 Periodic design reviews throughout the design process
 Confirmation that the design outputs conform to the design inputs through:
Design verification (“did we design the device right?”)
Design validation (“did we design the right device?”)
Translation of the design into manufacturable specifications
 Clear documentation of the entire process in a design history file or DHF.

Design Controls are mandated by:

  • 21CFR 820.30 in the US (Quality System Regulation)
  • 93/42/EEC in EU (MDD – Medical Devices Directive)
  • New MDR 2017/745
  • ISO 13485:2016 (Quality management systems) in Europe and around the world

21CFR, Sec. 820.30 Design controls
(a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a) (2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

(a) (2) Devices automated with computer software; Tracheobronchial suction catheters;Surgeon’s gloves; Protective restraints; Manual radionuclide applicator system; Radionuclide teletherapy source

 

There are 9 major subparts to the 21 CFR 820.30 regulation:

 (b) Design and development planning.
 (c) Design input
 (d) Design output
 (e) Design review
 (f) Design verification
 (g) Design validation
 (h) Design transfer
 (i) Design changes
 (j) Design history file

DESIGN CONTROL IS A GOOD PRACTICE

In simple terms, it is the complete control over the design development of your product.

Design Controls designates the application of a formal methodology to the conduct of product development activities.

Design controls make systematic assessment of the design an integral part of development. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier in the development process.

Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.

In practice, design controls provide managers and designers with improved visibility of the design process. With improved visibility, managers are empowered to more effectively direct the design process—that is, to recognize problems earlier, make corrections, and adjust resource allocations.

Designers benefit both by enhanced understanding of the degree of conformance of a design to user and patient needs, and by improved communications and coordination among all participants in the process. 

Design Control and the Verification of Product Requirements
 Good Business Practice
 Results in increased customer satisfaction
 Fewer post market changes
 It’s the Law

GET SUPPORT / CLARIFY YOUR DOUBTS

Reach out to us for advice, questions or support about implementation of design control for development of new device or remediation of existing DHF and design control process to improve compliance and efficiency.

Write to info@dhf-experts.com or fill out the form.