Accelerating Time to Market for Medical Device Manufacturers
Quality, reliability and safety can compete with the business needs of medical device manufacturers. Stringent quality requirements, market pressures and product complexity all combine to create a host of difficult challenges to manufacturers.
Risk and regulation management can often have an adverse impact on time-to-market and the cost of manufacturing medical device products. Today, manufacturers have to meet, manage and maintain increasingly rigorous compliance standards while, at the same time, balance increasing commercial pressures.
At Ideagen, we support medical device manufacturers with key business functions that will ensure quality, reliability and safety are achieved throughout the product lifecycle. These include preventive actions to combat potential adverse events as well as reactive management methods. Our solutions:
- Modernise and strengthen your quality management system
- Ease Compliance with standards and regulations
- Create a culture of reporting and safety
- Substantially improve operational performance and efficiency
- Control and protect reputation and brand
- Help Anticipate and prevent problems and issues
Achieving and maintaining compliance with the FDA’s 21 CFR 820 and Part 11, ISO 13485, ISO 14971 or Medical Devices Directive requirements is of vital importance.
Ideagen's products and services cover this business need and deliver operational excellence in advanced manufacturing.
Contact Us Today To Discuss How