Medical Devices
The Medical Device industry has some very specific challenges relating to regulatory compliance, FDA approval (United States), CE mark (Europe), MHW approval (Japan), Other national requirements and quality. These regulatory pressures and increasing complexity, coupled with the increasing globalization of the market, creates an environment where quality, reliability and safety compete with the business needs to reduce time-to-market and increase product development efficiency.
Critical Business Issues (in priority order)
- Difficult and costly to comply with FDA regulations
- Quality is critical, but time consuming and difficult to achieve
- Cycle Time pressures are mounting
- As complexity and volume increase, costs are difficult to control
The MKS Integrity solution enables Medical Device manufacturers to:
- Show FDA compliance in minutes vs. weeks through automated traceability and report generation.
- Eliminate software related recalls and FDA scrutiny by dramatically improving quality through a single platform solution to manage all assets and activities from requirements through to test and deployment.
- Improve cycle time through improved product line management and full V-model reuse of features, requirements, design, code, and tests.
- Adapt rapidly to the unique processes of each organization, starting from a base medical device industry solution tailored to the individual company.
- Provide a scalable proven solution that handles complexity and volume challenges while improving cost efficiencies
