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

quality assurance