ISO 14971 Support

Engage Global Standardization Support

ISO 14971 is the regulatory standard that identifies what medical device manufacturers must do to protect against safety risks. Risk management applies to all stages of the life cycle of a medical device. Our consultants can free up time for your in-house team to focus on device development while we guide ISO compliance.

Have Confidence In Your  Strategy

We have helped worldwide medical device leaders deploy comprehensive risk management programs. Our analysts are experienced at identifying potential hazards, establishing associated risks and creating responsive processes and policies.

Avoid Common Mistakes

We have seen almost every possible pitfall that can occur during medical device development. This experience allows us to spot vulnerabilities in design and production plans. We can work with you toward the validations that get your product to market.

Secure An Expert Opinion Early

There are advantages to having an expert on board during the R&D phase. We can join your team at any point, but early intervention can save time, money and regulatory denials down the road.

How We Can Help


Having an expert working with you on the DFMEA, PFMEA and other aspects of risk analysis will increase your level of protection against unwanted surprises. While you focus on your medical device, we can focus on your compliance activities, like these.

Design Safety Verification

The purpose of design safety verification is to confirm that your medical device has been designed according to its specifications for its intended purpose. It is a major part of the approval process. Are you ready? Have confidence, with support from i3 design controls consultants.


PFMEAs eliminate or reduce process weaknesses, starting with the highest risk categories.