Understanding Regulatory Environment
As an experienced development partner, we strive to develop a comprehensive understanding of your regulatory environment and we integrate seamlessly with your regulatory compliance process.
In developing your product, we prepare a verification traceability matrix that aligns with your product requirements and documents verification conformance.
And certification commences with early prototypes. We undertake preliminary assessments with CDPs, more detailed assessments with Alpha units followed by final refinements with Betas thus ensuring compliance is achievable with the appropriate regulatory bodies.
Our regulatory capability extends to:
- On-site UL compliance testing
- Regulatory class I, II, and III devices
- Compliance with current FDA Quality System Regulations including FDA QSR 820.30 design controls
- Compliance with current EU directives for IVD devices and MDD devices requiring the CE Mark
- Electro-Magnetic Compatibility (EMC)
- Low Voltage Directive (LVD)
- CLIA Waiver
- In Vitro Diagnostic Medical Device Directive (IVDMDD)
- Audited and certified to AS/NZS ISO 9001:2008
- ISO13485:2003 Medical devices - quality management systems
- Software processes based on IEC62304:2006
- In-house shielded rooms for first pass EMC testing and evaluation
Our manufacturing facilities have produced 5,500 UL certified, CE marked instruments for international distribution by our clients
To find out more about about Invetech's expertise contact us.