Introduction to Design Controls in medical devices

[Adam Fleming]

Design Control for medical devices can be understood as an integrated set of verifiable and demonstrable steps and practices undertaken by the manufacturers of these devices. Design Control for medical devices comprises a set of steps relating to the quality and consistency of medical devices, whose manufacturers take to ensure that:

1. There is safety in the medical device under manufacture
2. All the recommended and required steps and procedures that go into manufacturing the device are what were meant to be developed
3. Proper and sufficient methods have gone into guaranteeing that the product meets the required standards and procedures needed for ensuring its safety and helping it meet customer requirements.

Design controls for medical devices are integral and vital to ensuring that the medical device meets not only all the required and prescribed regulatory procedures and guidelines; but also, the customer’s expectations and needs.

Design Controls are part of both FDA and ISO expectations

Both the FDA and the ISO have regulatory requirements from medical vis-à-vis Design Control. FDA 21 CFR 820.30 deals with the FDA’s requirements for design controls for medical devices, while the ISO spells out design controls for medical devices in sub-clause 4.4 of ISO 13485.

The FDA 21 CFR 820.30 and the ISO 13485 may be formed by different regulatory or standards bodies; yet, both are essentially similar. The FDA 21 CFR 820.30 and the ISO 13485’s general requirements relate to the following:

• Design and development planning
• Design output
• Design input
• Design review
• Design verification
• Design validation
• Design transfer
• Design changes.

Design Controls got appended to current Good Manufacturing Practices (cGMP) requirements for medical devices by the Safe Medical Device Act of 1990, which authorized the FDA to add this activity to cGMP. Although Design Control is critical to the medical device industry, and despite the fact that they have become part of cGMP for a long time now; Design Control features prominently among preventable voluntary recalls.

A full understanding of the area of Design Control

A proper understanding of Design Control is essential for ensuring product quality, which in turn means that consumers are using products that are safe and effective, and also helps to prevent recalls.  This very important understanding will be imparted at a highly educative and valuable learning webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma; will be the speaker at this 90-minute webinar. Please visit http://www.compliance4all.com/control/w_product/~product_id=501585LIVE to register for this highly useful learning session.

An understanding of the regulatory expectations

The aim of this session is to cover the basics of Design Controls for medical devices, which will help participants create a Design Control process that becomes a competitive strength for their company.  Susanne will help participants of this webinar understand regulations and expectations, review enforcement case studies, understand the Design Control Process, identify best practices and prepare a plan for inspection readiness.

She will cover the following areas at this webinar:

• Overview and Definitions
• FDA Expectations, Regulations
• Design Control Process
• Planning
• Design Inputs
• Design Outputs
• Verification
• Validation
• Design Review
• Design Transfer
• Design Changes
• Design History File
• Linkages to other Quality System Requirements
• Lessons Learned and Enforcement Case Studies
• Best Practices
• Preparing for an FDA or NB Inspection.