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Person Responsible for Regulatory Compliance

As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC). This individual (or...

Brexit and the changes to medical device regulations coming in 2021

The United Kingdom’s exit from the European Union has had far-reaching ramifications for a wide range of industries, including medical device manufacturing. If you’re a medical device firm selling – or looking to sell – into the UK, significant changes are coming in...

IVDR: What You Need to Know about Europe’s Changing IVD Market

The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements. Under this...

FDA Cracking Down on Poor Performing EUA Tests

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or...

The Final Guidance: FDA on Multiple Function Device Products

On July 28th, the FDA issued the final guidance pertaining to multiple function device products (MFDPs). Products may include several functions and the FDA is now in the process of accommodating for such devices, which can get complicated.MFDPs are products with one...

News and Resources

Regulatory Relief to Support Economic Recovery

Regulatory Relief to Support Economic Recovery

On May 19, 2020, President Trump issued Executive Order No. 13924. This order instructed HHS and FDA to “review any regulatory standards that they have temporarily rescinded, suspended, modified, or waived during the public health emergency,” in order to “determine...

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