Meet compliance and regulatory challenges
The PDS provides a single version of critical compliance data and documents for medical device manufacturing. The PDS also delivers critical content and process management that facilitates compliance with global regulations pertaining to quality systems management and electronic records and signatures. Tasks such as creating a Design History File, generating links between requirements and product designs, and capturing audit trails of all electronic activities are automated.
Dynamic information product delivery systems have well documented benefits for Life Sciences companies:
Manage the total product life cycle
Manage your documentation products the way you manage your product development.
Documentation is a product with all the same challenges and requirements of the product development process. Good documentation done up front, can guarantee your documentation can pass an FDA audit, while still saving time, money, and speeding the your product to market.
PTC solutions for Medical Device companies can help you:
- Comply with 21 CFR Part 11, 21 CFR Part 820, ISO 13485 and the European MDD (2007/47/EC)
- 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
- Reduced translation costs to meet the European MDD (2007/47/EC)
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Featured Customer Success Story:
- Readabout how Sigma-Aldrich optimized catalog publishing with PTC’s Arbortext solution