Supporting the needs of startups and small manufacturers

Although Emergo Group has offices worldwide, most of our clients do not. In fact, more than 80% of clients have fewer than 25 employees and they count on us to help them access major medical device markets worldwide. Small manufacturers have always been the key component of our client base, and since our founding in 1997, we remain focused on helping small medical device companies grow.

Helping clients focus on growth, not regulations

Small and start-up manufacturers make up the backbone of the medical device industry. We fully understand that getting your product approved for sale quickly in a specific market is vital to your success. We also know that most firms do not have an unlimited amount of money to accomplish this goal. Understanding these particular business needs allows us to better provide the service and support you require to gain regulatory approval and commercialize your product quickly and cost effectively.

Whether you require assistance with regulatory approval of your device, quality system implementation, in-country representation or distribution, Emergo Group has the resources and experience to support your efforts to grow. We offer a variety of services tailored to your business and operational requirements to ensure that you can focus on growth while meeting regulatory compliance requirements.

Our 10 most popular services for small companies include:

  1. US FDA 510(k) application preparation
  2. CE Marking certification for Europe
  3. Outsourcing QA/RA compliance functions
  4. ISO 13485 quality system implementation
  5. US FDA Quality System Regulation (QSR) compliance
  6. European Authorized Representative for CE Marking
  7. Canadian Medical Device License preparation
  8. Internal audits of ISO and GMP quality management systems
  9. Medical device distributor search and evaluation
  10. Clinical trial strategy and management

Emergo Group’s offices in North and South America, Europe, Asia and Australia can provide you with access to 90% of the global medical device market while simultaneously ensuring your compliance obligations are met.