Elcam Medical Mitigating The Approval Risk – By Placing their documents on Pre-Audit alert system that implemented the complete V&V Medical Device module

Based 2,323 California biomedical companies research, here are the main 10 threats those companies has reported on

  • #1 – FDA regulatory / environment
  • #3 – R&D productivity
  • #7 – Intellectual property protections
  • #8 – Ability to demonstrate effectiveness
  • #9 – Product liability
  • #10 – Unprepared workforce

The unspoken rule is that at least 50% of the studies published even in top tier academic journals – Science, Nature, CellPNAS, etc… – can’t be repeated. More than that if there was a development behind those studies it was impossible to recreate the documentations requires utilizing their business potential.

According to the same research the following answers given to the question: Why did the company delay the research or development project? Were as follows:

  • 40.2% – Funding not available (Second Round)
  • 27.8% – Regulation (FDA, EPA, SEC)
  • 25.8% – Change in corporate priorities or strategy
  • 4.1% – layoffs
  • 7.2% – Other

Orcanos Implementing NPI (New Product Introduction) for one of the legacy Israeli Medical Device company Elcam Ltd. In this project the focus was on getting the project started on the correct regulatory path and have taken the initiative documents created by the R&D group into a preset system that control and governance the regulatory path selected by the organization. The overall idea was to define the development path in which the specific product shall be using and to match the perfect system that will control and governance each step in the development lifecycle. To achieve this goal we have selected QPack Medical™ system that accepted the validation documents and for each document the system created set of KPI (Key Performance Indicators) as well as KRI (Key Regulatory Indicators) that triggered QPack Medical alert system with Pre-Audit notifications.


Mitigating Audit-Submission Risks



For example:

The insertion of MRD documents during the Idea/Concept stage trggered the following alerts


  • Market Requirements missing coverage matrix
  • Market Requirements maturity based on functional test results
  • Market Requirements missing due date
  • Unapproved market requirements
  • Readiness for PDR review



  • Missing Market Requirement Document
  • Missing Market Requirement  Specifications
  • Market Requirements missing traceability to product requirements
  • Market Requirements missing validation procedures






Leave a comment