Often the inhouse design team of medical device companies focuses on core research and development and that’s what keeps them motivated and excited. However, in the due course many mandatory requirements of DHF creation and maintenance are overlooked.

We’ve been helping hardware medical device, Software as a Medical Device (SaMD), IVD, and combination product companies by taking ownership of product documentation.

We interface with the R&D and core product development team to create or update Design History File (DHF), follow Engineering Change Notification (ECN) process for continued product compliance, define the right testing as per the end goal (e.g., FDA approval/clearance, CE Marking, letter to file, change notification, etc.), and ensure traceability between user needs, design inputs/outputs, verification and validation activities, and risk assessment for a robust product design documentation that serve as an evidence for a safe and effective medical device during any regulatory approval or FDA inspection process.

Product Documents and Traceability Requirements

Amongst the various product development and evolution documents that we’ve created in the past, the most popular and common ones are as follows:

  • User needs identification and definition
  • System requirement specifications
  • Software requirement specifications (SRS)
  • Software Design Specifications (SDS)
  • Architecture design chart
  • Software Level of Concern
  • Traceability matrix
  • Software Development Environment Description (SDED)
  • Mobile application classification and documentation
  • Risk assessment (ISO 14971)
  • Risk management updates
  • Supplier identification
  • Shipping labels
  • Instructions For Use
  • Labelling documents
  • Label review for compliance
  • Performance testing
  • Bench testing
  • Third-party – IEC 60601, ISO 10993, ISO 11607, etc.
  • Device History Record (DHR) & Device Master Record (DMR) creation and updates

With the team of Biomedical, Software, Electrical, and Mechanical Engineers with background in servicing and testing, we truly understand your product, and help you present the device to the regulatory authorities or Inspectors in the manner it deserves. We leverage our experience for your success and augment your team, so the R&D team can focus on what they do best.


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