Medical Device Directive, Third Edition Update
D.L.S. Conformity Assessment understands your product and the requirements that you must comply with – from risk assessment and essential performance requirements to the completed Medical Device Directive 2007/47/EC (MDD) certification process.
The D.L.S. streamlined program for medical device approval includes the following aspects:
- Transitional Analysis from 2nd Edition compliant devices or earlier
- Comprehensive Risk Assessment Evaluations - Using ISO 14971 guidelines
- Detailed Construction Review
- Formalized testing plans and procedures
- State of the art testing equipment
- Experienced iNARTE Certified safety engineers
- Early Design Evaluations
- Real-time mitigation and consulting services
D.L.S. can ensure your product meets all requirements of the Medical Device Directive, effectively allowing your product to bear the CE Mark, and to market your equipment in the European Union.
D.L.S. Conformity Assessment is also a UL Certificated Agency and can address all your North American compliance needs for this revision of UL 60601, which took effect in summer of 2013.
If your medical device needs EMC testing as well, we can perform that for you too. More information here.
For more information, please contact Jack Black at 847-537-6400 or request a quote online through the sidebar on the right.