Regulatory Consulting

Regulatory Compliance Consultants

The FDA is responsible for regulating the production and monitoring the safety of high-quality medical devices. Before the device can be sold in the U.S., the manufacturer must obtain FDA approval by presenting evidence that the device is safe and effective for a particular use. What’s more, regulatory control increases with the device class and its associated risk, which adds further complexity to an increasingly complicated process. 

Clinical Evaluation Reports

All medical devices sold in the EU must have a Clinical Evaluation Report (CER) as part of its technical documentation to satisfy the new EU Medical Device Regulation (MDR) requirements. A comprehensive analysis of pre- and post-market data relevant to a medical device, a Clinical Evaluation Report demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.

Other Services

EU MDR and IVDR Transition and Technical Documentation Compilation

We’ll help you navigate the complex regulations, processes and protocols to achieve regulatory compliance, on-schedule. Backed by proven procedures and tools, our team has extensive experience helping multinational companies with their EU MDR and IVDR transitions and implementations.

Learn More >

FDA Medical Device Regulatory Compliance Audit Program – MDSAP

The Medical Device Single Audit Program (MDSAP) offers a harmonized approach to evaluating the quality systems of medical device manufacturers across five markets: US, Canada, Australia, Brazil, and Japan. 

Learn More >

FDA Medical Device Regulatory Compliance Consultants

At Sterling Medical Devices, we have FDA medical device regulatory compliance consultants that help you achieve regulatory, quality, and clinical compliance with country-specific requirements. With intelligence on the most up-to-date requirements, our FDA regulatory consultants will lead all clinical and regulatory program management activities, so you don’t have to.

Learn More >

Medical Device Post-Market Development Support, Surveillance & Remediation

Our team of experts can help you create PMS and post-market follow-up (PMCF) plans and reports; integrate risk, clinical evaluation reports (CER), and PMS processes; and develop and execute on post PMCF surveys and usability data.

Learn More >

Resources

Hands compare spinal x-rays

January 15, 2021

Three Takeaways from the Human Factors Engineering & Usability Studies Congress

In early December, I had the good fortune of attending the Human Factors Engineering & Usability Studies Congress online. Although the event could not be held in person, for obvious reasons, it...
Read More >
Sterling Medical Devices's Dan Sterling speaking

December 17, 2020

Here in New Jersey, Sterling Medical Devices Makes Med Tech to Order

Dan Sterling of Sterling Medical Devices | Screenshot by Esther Surden Suppose you are developing an implant that involves both hardware and software, or an external device for diagnosing a...
Read More >
healight

November 5, 2020

Healight: The Moonshot Not Yet Heard Round the World

Imagine a technology so innovative and groundbreaking in its potential impact that its sponsor is calling it “a moonshot” and “an opportunity so big you could build an entire company around...
Read More >

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis