Medical Device Testing

Compliance and testing to help you with FDA & Health Canada submissions for your products

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Why conduct testing & how can Megalab help?

Manufacturers need to comply with the 60601 series of tests in order to sell medical electrical equipment. It is a requirement for FDA/Health Canada submissions and is also mandated by the EU and other international bodies.

Need help getting your medical device to market? MegaLab can assist with this.

We have full capability for testing to IEC/EN/ANSI/AAMI/CSA 60601-1, including particular and collateral standards.

MegaLab consists of a full lab to cover specific standards such as IEC 60601-1-11 for home healthcare equipment.

In addition to product safety testing, we can assist with the following:

  1. Risk Management and Usability Consulting.
  2. Pre-Compliance design reviews
  3. GAP Assessments between standard editions.

Applicable International Medical Device Standards

General applicable standard IEC 60601-1

Additional collateral standards may apply based on products intended use and environment. For Example, IEC 60601-1-11 for home use medical equipment and IEC 60601-2-47 for Ambulatory ECG. MegaLab can help you with these and numerous other collateral standards.

ISO 14971 Risk Management

With hundreds of medical device test reports being completed by our medical team we are more than qualified to evaluate your risk management file. If you also need help designing a risk management file we can also offer consultation. A word of advice, get started on risk management as you design your device from day 1, not as an afterthought.

Usability IEC 62366

Megalab can help with review and with building a usability file from scratch.

IEC 62304 Software Lifecycle process

Megalab can evaluate your software to ensure it complies with the 62304 standard.

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