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Medical Device Industry – Regulatory Compliance


Regulatory requirements are defined by national bodies such as the FDA in the United States or the Medical Device Directive in the European Union. With the increased globalization of the market, five regions have joined together to form the Global Harmonization Task Force (European Union, United States, Canada, Australia and Japan) to drive the development of guidance documents that harmonize some of the regulatory and trade requirements between these member countries, lowering the trade barrier and encouraging convergence in regulatory practices.


  • FDA CFR 21 Part 11 – Electronic Signatures – Companies that develop products for the American market in FDA regulated industries must comply with CFR 21 Part 11 regulations governing electronic record signatures. The regulations can be very strict and require a literal interpretation in certain circumstances. PTC Integrity provides electronic signature capabilities that satisfy CFR 21 Part 11 and PTC Integrity has met and exceeded the audit requirements of our customers in the life science industries.

  • FDA CFR 21 Part 820 – Quality System Regulation – The Quality System Regulation (QSR) applies current Good Manufacturing Practices (CGMP) which govern the design, manufacture, packaging, labelling, storage, installing, and servicing of all finished devices intended for human use. The goal is to ensure devices are both safe and effective. However, compliance requires the creation and maintenance of a series of documents that describe design and production of the device. These documents are the Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Quality System Record (QSR). The documents contain all device and production specifications and quality assurance procedures utilized throughout the development life cycle. These records can contain thousands of files and documents, and a request from the FDA can cost person-weeks of searching and compiling to satisfy. With PTC Integrity's central storage point and traceability management, the time required to produce a the necessary input to these records can be reduced to minutes.


  • European Medical Device Directive MDD 93/42/EEC – The Medical Device Directive (MDD) is a harmonization of standards for the design, manufacture, packaging, labelling, storage, installation, and servicing of medical devices in the European Union. Compliance requires the creation and maintenance of a Technical File similar in content and scope with the Device Master Record mandated in the FDA CFR 21 Part 820. The PTC Integrity solution manages all engineering processes and connects all engineering artifacts, including requirements, software specifications, code, tests, as well as a complete risk analysis or risk management file, thus ensuring comprehensive life cycle traceability. With PTC Integrity's automated reporting demonstrating compliance is reduced from a manual task that can take weeks to an automated task that takes minutes.
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Reducing Manual Effort for Risk Management Compliance