PTC Integrity – Medical Device And Lifescience

SPK Recommends PTC Integrity Lifecycle Manager as the Best In Class Solution for Medical Device/Lifescience Companies

SPK and Associates has been working with Medical Device Manufacturers (Large and Small) for many years.  We’ve seen and used all the tools available out there for the development process.   Our choice for Best In Class in the Medical Device Industry is PTC Integrity’s Lifecycle Manager.   Analyst such as Forrester Wave  agree stating  “PTC continues its leadership addressing regulated and “digital products” needs.

Medical Device / Life Sciences

Challenge PTC Integrity Lifecycle Solution Benefits
Challenge Management of Documentation and Records Solution
  • All documents can be stored and versioned with appropriate access controls
  • Automatically generates design history file DHF reports
Benefits Reduce effort to create DHF from weeks to minutes
Challenge Identification and Traceability Solution
  • Unique identification of each document and asset
  • Named trace relationships between all assets
Benefits Significant time savings
Challenge Document Controls and
Change Management
Solution
  • Automated workflow for effective process enforcement
  • Powerful change control automatically documents all allowed changes
Benefits
  • Automated and enforced processes
  • Full change history without overhead
Challenge Managing Risk and
Reducing Recalls
Solution
  • Simplified electronic tracking of requirements, risks and mitigations with relationships and dependencies
  • Automatically compute Risk Priority Number (RPN)
  • Automated support for V-Model with named relationships between requirements, design, and software assets and their associated verification and validation assets
Benefits
  • Reduced risk
  • Improve productivity while maintaining compliance and managing risk

See PTC Integrity Lifecycle Mgr Med-Device Solution In Action

Risk Management (ISO 14971)

The FDA and ISO 14971:2007 both acknowledge that the use of medical device technology entails some level of risk. The goal of risk management is to reduce product risk and to identify and understand the level of remaining risk and the impact that has on the user’s safety and the effectiveness of the product. PTC Integrity provides a configurable framework to apply the risk management practices of ISO 14971:2007 which allows organizations to improve the safety and effectiveness of their devices and enables them to demonstrate regulatory compliance. The benefits of using PTC Integrity for risk management of medical devices include:

  • Compliance with ISO 14971:2007 — The PTC Integrity solution for medical device companies provides a configurable Risk Management platform that leverages ISO 14971 risk management methodologies through the implementation of Hazard and Risk Analysis documentation, coupled with risk management and risk control processes that can be traced to product design as well as verification and validation records.
  • Automation of Complex Reports — ISO 14971:2007 and the regulatory requirements based upon this standard have specific reporting requirements, including the generation of a Risk Management File which details the risk analysis, risk evaluation, the implementation and verification of the risk control measures; and the assessment of the acceptability of any residual risk(s). PTC Integrity automates the generation of this report through built-in traceability reports, allowing companies to easily export all of the risk documentation and any traced artifacts and verification results.
  • Configurable Risk Metrics and Policies — Organizations can tailor the PTC Integrity solution and refine the terminology to suit their needs. For example, the values for Severity and Occurrence on a Risk may have their definitions modified to be quantitative rather than qualitative. The computations used to determine Risk Level (Acceptable, Unacceptable, Investigate) may also be tailored for the organization on a per-project basis to allow the solution to be applicable to a variety of devices with distinct intended uses. Support is also provided for RPN calculations of Risk.
  • Risk Coverage Charting and Reporting — Through real-time charting and reporting, PTC Integrity enables engineers to at a glance determine coverage across each of the risk domains. This includes the ability to identify Hazards that have no corresponding Risks, Risks that have no corresponding Mitigation or Control Measure, as well as Risk Control Measures which have not been verified.

Data Sheets

Customer Stories

SPK and Associates Integrity Productivity Add-Ons

  • One-Click Generation Of Multi Page Excel documents with complex trace relationships and fields (just as your QA/RAC wants to see it!) via SPK’s Report Engine
  • Reduce The Number Of Document Domains!  Work in One Domain. And then do One-Click Restructuring of your document and automatic application of multi-type trace relationships via SPK’s Document Restructuring Utility
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