From reviews of the design documentation when your company is experienced in Design Control compliance, to preparing and completing the required deliverables to support submissions, to managing the project and letting your engineers do the most important thing, -D-E-S-I-G-N, The CRO Group’s Design Assurance services are key to your company’s success.
This applies when the product is stand alone software – a mHealth app or a web app, a combination, and coupled with a sensing accessory requiring IEC 60601 testing. When it comes to medical device software, the USFDA, EU and Canada all recognize IEC 62304, and The CRO Group can assist or take the lead in generating the deliverables required for your design, regardless of development approach – even SCRUM.
One of the keys to successful risk management for regulated industries, whether in the traditional product realisation process of design, or in later production, or post-production, is to get started.
As soon as conceptual designs are available, the risk management process should begin in earnest. From performing traditional hazard analysis using FMEAs and FTAs, as well as the new tools including HAZOPs and HACCPs, risk management helps us answer 3 important questions: “What can go wrong?”
“How often and how severe an outcome is possible?” and
“What are we going to do about it?”
These same questions as well as most of the tools apply to all aspects of product realisation – from Purchasing and Supplier controls to Warehousing.
A big part of successful medical device manufacturers’ risk management programs is applying ISO 14971. While the standard was intended to support medical device design, many of its principles are usable throughout product realization, required under ISO 13485.
The CRO Group is experienced in assessing your risk management process, training, establishing tools, and performing the various RM techniques. Click here if you have an immediate need for risk management services.