Regulatory Strategy Support

Home > Regulatory Strategy Support

Defining Your Regulatory Strategy Is Key

Our team has decades of experience helping medical device companies make sense of global regulatory landscapes in countries and regions all over the world. Whether it is in the US, EU, Canada, or elsewhere, we take the guesswork out of deciding which approval pathway is best for your device.

A regulatory strategy will include the interpretation of the country-specific regulatory requirements including:

Product code and regulation number determination
Classification determination
Identification of applicable standards and guidance documents
Confirmation or identification of potential predicate devices
List of applicable tests
Premarket pathway strategy
Quality system requirements
Claims and labeling review or guidance.

Contact Us

Name
First Name Last Name
Email*
Phone*
Company*
Message*
Phone
This field is for validation purposes and should be left unchanged.

Sterling can help.

A regulatory strategy is the first step in the long journey of bringing your device to market. We’ll help you navigate the complex regulatory maze and bring your medical device to market quickly and cost-effectively. Contact us now! Let our experts guide you through this important process, every step of the way.

About Sterling Medical Devices

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

Share this!

Resources

Professional on computer reviewing ISO documents.

October 17, 2023

What’s New in ISO 10993-17:2023?

In early September, the International Organization for Standardization (ISO) released new ISO standards for medical devices: the ISO 10993-17:2023 (en) Biological Evaluation of Medical...

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.

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....

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!