PTC’s Solutions for Compliance in Medical Device Design & Development
Manage Quality Early & Across the Total Product Lifecycle to Reduce Risk, Streamline Compliance while Accelerating Innovation
Medical device manufacturers are facing very tough challenges today including demand for innovation, complying with strict evolving environmental and regulatory requirements, and shrinking price premiums, not to mention intense competition which demands faster times-to-market. With the recently published proposed rule for the FDA’s Unique Device Identification (UDI), medical device manufacturers must now meet new challenges. These increasing regulatory demands require more cross functional needs across corporate regulatory, global supply chain, packaging, product lifecycle management, corporate quality and IT infrastructures.
The world's most respected medical device manufacturers are turning to PTC for solutions to these challenges and are benefiting from best practice capabilities and process management that facilitates compliance with global regulations pertaining to quality management systems with electronic records and signatures.
Tasks such as creating a Design History File, generating links between requirements and product designs, managing CAPA, Nonconformance and Complaint Records as well as UDI attributes and product data are all directly traceable in an integral product development system.
- Comply with FDA 21 CFR Part 11, 21 CFR Part 820, as well as ISO 13485 and the European MDD (2007/47/EC and 93/42/EEC)
- Manage the lifecycle of product data including initial data definition, regulatory reviews and Change and Configuration Management in support of global Unique Device Identification regulatory requirements
- Easily manage and gather all product information necessary for audit requests and regulatory submissions including the Design History File (DHF), Device Master Record (DMR) and Unique Device Identification (UDI)
- Implement Closed Loop Quality processes to deliver a high quality, safe and reliable product, through integral CAPA, Nonconformance and Customer Complaint handling
- Reduce risk and improve product quality and reliability by facilitating a risk-based approach to product design and validation aligned with ISO 14971
- 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 the proliferation of Embedded Software as well as standalone Medical Device Data Systems and implement software design controls that support CFR 21 Part 820 and IEC 62304 with solutions for Application Lifecycle Management
- Meet compliance deadlines for RoHS and REACH guidelines with solutions for Environmental Compliance
- Enable Design in Context in a heterogeneous environment, to Design Complex products with more variants using multiple tools