Meet compliance and regulatory challenges

Medical device manufacturers are facing some very tough challenges today including demand for innovation, complying with strict environmental and regulatory requirements, and shrinking price premiums, not to mention intense competition which demands faster times-to-market. 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. 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 medical device and life sciences companies:

Manage the total product life cycle

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 your product to market.

The PTC Arbortext product suite 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 for your product documentation as well as your products.
  • 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)

Customer Stories

Tags

content strategy, globalization, make your business case, regulated industries, single-sourcing

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