Medical Devices

Hardwire Compliance as You Generate the Future of Medical Device Development

Medical device manufacturers are facing some very tough challenges today including demand for innovation, complying with strict regulatory requirements, shrinking price premiums, faster time-to-market pressures and intense competition in medical device development. The world's most respected medical device manufacturers are attacking these problems by implementing the PTC Product Development System (PDS).

The PDS provides a single version of critical compliance data and documents for medical device manufacturing. It also delivers critical content and process management that supports demanding regulatory requirements, such as electronic records and signatures, document control, change control, and auditing, Tasks such as capturing records required for medical device regulatory compliance, linking design outputs to requirements inputs, and updating related records when source information changes are automated.

PTC solutions for Medical Device manufacturing companies can also help you:

• Comply with 21 CFR Part 11 and 21 CFR Part 820
• Improve product quality and reliability by facilitating a risk-based approach to product design and validation
• Easily manage and gather all product information necessary for audit requests including the Design History Files (DHF) and Device Master Records (DMR)
• Execute closed-loop change management which integrates CAPA requirements with the electronic content that must be modified
• Maintain a central repository for important records including SOPs, Validation & Qualification documents, Risk Management documents, training records, design files, purchase specifications, test methods & procedures, DOE documentation and requirements specifications
• Manage CAPA, Complaints and Nonconformances
• Manage your clinical trial and post market surveillance data

Learn More About our NetRegulus Products - Quality and Study Management Solutions