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
- Quality Management System (QMS) ISO 13485 Support
- ISO 14971 Risk Management support
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
environmental compliance
- REACH
- RoHs
- WEEE
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?
Compliance & regulatory support FOR YOUR NEXT PROJECT?