Engineering Tools & Services for Medical Applications
CERTON, a Cyient company, understands that both schedule and budget are at risk during the development lifecycle of a project. CERTON can immediately put our expertise to work in order to help your team effectively plan and execute the right tasks, at the right time, and in the right order to ensure all objectives are satisfied to schedule.
Our independent validation and verification (V&V) services provide an independent review of your device to support your FDA/CE Mark submission. This is especially vital for companies who may only have a limited number of personnel and are not able to provide the necessary level of independent review.
- Quality system review, then develop and implement a remediation plan, if applicable
- Complete Quality System development
- Risk assessment & hazard analysis consulting
- Process validation – Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ)s
- Part 11 & HIPAA Compliance review
- Software quality assurance
- Minimizing development time and cost
- Design documentation services
IEC 60601 Electrical and IEC 62304 Software Systems for Medical Control & Protection
CERTON Medical provides services for projects utilizing both IEC 60601 Electrical and IEC 62304 Software Engineering Standards for Medical Applications. From developing robust software and electronic hardware requirements, to verification and validation testing, CERTON has the knowledge and expertise to support your project’s entire development lifecycle from start to finish at any Safety Integrity Level.
Cyient Medical Technology & Healthcare
Cyient can partner with you at every stage—design, build, and maintain—to develop life-saving medical equipment so that you stay ahead of the ever-expanding competition. Our core capabilities allow us to deliver expertise spanning the medical device life cycle. ISO 13485 certified for both design and manufacturing, we provide solutions customized to your needs and are experienced in multiple Medtech industry segments with a focus on diagnostic imaging, in-vitro diagnostics, and cardiology. Click here to learn more.