Medical Device Post-Market Development Support, Surveillance & Remediation

electronic measuring instruments in hitech computer laboratoryBefore bringing your device to market, you went through a series of rigorous regulatory processes to get it approved for commercialization. But because some risks manifest over time, both American and European markets require post-market surveillance (PMS) of your device to ensure its continued safety and effectiveness in the real-world setting.

Activities related to the post-market evaluation of your device, however, can be time-consuming, cumbersome, and complex—which presents a challenge for many manufacturers. At Sterling Medical Devices, this is what we do—and we do it exceptionally well.

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.

We’ll also help you identify areas of negative impact to mitigate the risk of potential issues, then provide easily attainable avenues for remediation when necessary. Our remediation expertise includes:

  • Gap analyses
  • Inspection readiness and audits
  • Compliance consulting and remediation
  • DHF and technical documentation remediation
  • US FDA 483s, warning letters, untitled letters, FDA recalls, off-label promotion, false claims, consent decrees, and global resolutions

At Sterling, we understand the legal requirements of the FD&C Act and related statutes enforced by the FDA. We also know the general legal and regulatory requirements for medical product development, marketing approval, reporting requirements, inspections, and enforcement actions. In other words, when it comes to the increasingly complex world of post-market surveillance, follow up, and remediation, we’ve got you covered. 

Resources

person typing on a keyboard with security graphics overlay

July 23, 2019

Why Cybersecurity is Becoming More Important in the Medical Device Industry

Cybersecurity in the medical device world has evolved from a footnote to a front-page headline. Articles with titles like “Medical Devices are the Next Security Nightmare” (Wired) and “Medical...
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