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

verification and validation testing

July 7, 2021

Do you know the difference between verification and validation?

Medical device verification and validation (V&V) are crucial steps in the medical device development process. But what’s the difference between the two, and why do we need them? Verification...
Read More >
View More Blogs

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.
Read More >
View More Videos
active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
Read More >
View More Case Studies

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