REGULATORY AFFAIRS &

cOMPLIANCE

Health Care & Bio-Medical Industries are remarkably dynamic especially in terms of regulatory & legal frame work. To ship your units across the globe, it is mandatory to be compliant to ever changing regulatory guidelines. To have a hassle free legal frame work, firms need robust pathway through the regulatory team.

iLenSys helps medical device manufacturers to focus on optimized efforts and resources to achieve a faster time-to-market for their products.

Industries we serve

Medical Devices
In Vitro diagniostic Devices
Lab & Measurement Equipment
control equipment
We serve our expertise to help customers in the following areas of Regulatory compliance

 

1. Regulatory Compliance Risk

  • Misalignment of interpretation of the MDR/VDR requirements and Compliance Support for Lab, Measurement, & Control Equipment
  • Uncertainty regarding MDR/IVDR requirements and infrastructure (e.g. EU UDI, EUDAMED, Test Laboratories)
  • Technical File contents not compliant to EU IVDR/MDR
  • Supporting data not available to support the Technical File update in a timely manner

 

2. Product Risk

  • Shifting landscape of requirements since MDD/IVD may require additional product performance information
  • Additional testing required for compliance
  • Misinterpretation and unknown new requirements

 

3. Quality Risk

  • Quality System (e.g. PMS, PMPF, RMP, CER, PER) is not compliant to new MDR/IVDR requirements)

 

4. Business Risk

  • Business continuity for countries where CE marked products are sold or CE Mark is necessary to maintain the registrations outside of the EU
  • Lack of timely guidance from regulatory authorities that leads uncertainty in the project
Regulatory affairs support
  • CE marking support for MDR & IVDR
    • Gap analysis
    • Regulatory dossiers
    • Performance evaluation report
    • Scientific validity reports
    • Third party LAB testing

read more.

quality assurance

  • Quality Management System (QMS) ISO 13485 Support
  • ISO 14971 Risk Management support

read more.

support for lab,measurement & control equipment
  • FCC requirement support
  • CE requirement support
  • ICES requirement support
  • In-Country regulatory support
  • Support in NRTL mark
  • Support in CB certification

read more.

environmental compliance
  • REACH
  • RoHs
  • WEEE

read more.

our strengths

  • Qualified and Experienced and resources
  • Global regulatory exposure
  • Our standard tools and templates
  • Service delivery strategies
  • Defined process and quality checks
  • On time delivery
LOOKING FOR A QUALITY AND AFFORDABLE
Compliance & regulatory support FOR YOUR NEXT PROJECT?