Medical Device Testing
Why do I need Medical Device Testing?
FDA and Health Canada require that manufacturers comply with the 60601 series of tests to sell medical electrical equipment in their respective countries. Other countries such as the EU may have different requirements to sell medical equipment. Rest assured, our tests will meet international standards, so you’ll be able to sell your medical devices.
Let us help you get your device to market
Testing Partners can complete all testing, including particular and collateral standards, for the IEC/EN/ANSI/AAMI/CSA 60601-1.
Testing Partners offers full laboratory support to cover standards such as IEC 60601-1-11 for home healthcare equipment.
In addition to product safety testing, we also offer:
- Pre-compliance design reviews
- Risk management and usability Consulting
- GAP Assessments between standard editions
Comprehensive medical device standards
Standard Support for IEC 60601-1
Testing Partners is here to assist you with collateral standards relating to the IEC 60601-1. These standards may apply based on the product’s environment or intended use. As an example – the IEC 60601-1-11 for home use medical equipment and IEC 60601-2-47 for Ambulatory ECG.
Risk Management for ISO 14971
When you develop a new product, you must plan on risk management in all phases, from design to implementation. Risk management should never be seen as an afterthought. Our team will run hundreds of tests on your product to ensure the product complies with all standards and can be safely sold around the world. Call us today for your initial consultation.
IEC 62366 Usability
Testing Partners will help you build and review a usability file from scratch.
IEC 62304 software lifecycle process
Our team will evaluate your software to ensure it is in full compliance with complies with the 62304 standards.
Testing Partners group product safety services
PRECOMPLIANCE
Construction review
Save time and money by scheduling a consultation and pre-compliance review now.
GLOBAL APPROVALS
Product safety testing for CE marking
To be successful you need CE marking. Our testing and compliance will ensure you receive it.
NRTL/OSHA
Nationally recognized testing
You can get full-service laboratory and (NRTL)/C approvals. We’ll help ensure your product meets OSHA specifications.
