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.

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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. 

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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.

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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.

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Resources

October 7, 2013

Guidelines to Follow When Creating A Medical Device Mobile Application

Guidelines to Follow Many new medical mobile applications are being developed for use on mobile platforms (smart phones, tablets, etc.). Before delving into the steps to be taken to develop a...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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