We at ProductLife Group have a thorough understanding of Business processes, enabling us to manage communication between the different stakeholders involved in a project – such as clinical, regulatory, quality, PMS team, manufacturing, and commercial – and advise clients on their processes or redefining and formalizing their processes.

Our services cover

Our services cover

Regulatory Affairs:

  • MDR assessment according to Annex I GSPR and Annex II Technical documentation and remediation activities
  • Support during product MDR submission
  • Person Responsible for Regulatory and Compliance (PRRC art 15 MDR)
  • European Authorized representative (MDR service)
  • UK/Swiss responsible person

 

Quality & compliance:

  • QMS 13485 support, including implementing full system with SOPs in compliance with MDR, ISO 13485
  • Supporting in creating DMR DHF procedures and processes
  • Supporting in QMS Audits

Biological evaluation:

  • Setting the Biological evaluation starting from the Biological evaluation Plan as part of Risk Management.
  • Physical-chemical characterization of MDs materials and Literature Review
  • MD categorization and relevant endpoints addressing
  • Test Strategy
  • Drafting the final Biological Evaluation Report

 

Post market vigilance:

  • Support in assessing PMS against MDR requirements
  • Implementing a PMS (Post Market Surveillance) procedures according to MDR requirements, including full set of templates

Risk management implementation:

  • Training of internal personnel on ISO 14971 and 24971
  • Assessment of the Risk management applied in the entire product Lifecycle according to ISO 14971 & 13485
  • Deploying Risk Based Approach within product lifecycle according to ISO 14971 & IEC 24971
  • Implementing Risk Management Tools

System/product performance:

  • Usability Testing support according to ISO 62366 with Risk Based approach including Combine products & SAMD

 

Software as medical device:

  • Support SW or Med app Development documentation according to ISO 62304/IEC 82304-1 (based on applicability)
  • Defining SAMD intended for use and Risk Class definition of SW and APPs
  • Support SW Certification Accordant to ISO 62304