Regulatory compliance for medical device startups and smaller manufacturers
We assist companies in all stages of growth, from startups seeking FDA 510(k) clearance for their first product, to established multinationals needing assistance with global regulatory strategy. However, our real passion is helping small businesses grow – getting them to the next stage by introducing a new product or accessing a new international market.
Helping clients focus on growth, not regulations
Small and start-up manufacturers make up the backbone of the medical device industry. Although Emergo has offices worldwide, most of our clients do not. More than half of our clients have fewer than 25 employees. 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. Startup and small companies that are not large enough for a full time QA or regulatory person often outsource their QA/RA responsibilities to us. Typically, one of our consultants will come on site a few days each month to ensure ongoing QMS and regulatory compliance. 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 or in-country representation, Emergo 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 7 most popular services for small companies include:
- US FDA 510(k) application preparation
- CE Marking certification for Europe
- Outsourcing QA/RA compliance functions
- ISO 13485 quality system implementation
- US FDA Quality System Regulation (QSR) compliance
- European Authorized Representative for CE Marking
- Internal audits of quality management systems
We understand the needs of small medical device manufacturers.
We get it. Having worked with thousands of small to mid-sized medical device companies and we know that money is often tight. We know all too well that growing medical device manufacturers have far more needs than money to meet those needs. The investment in regulatory compliance has big implications for the future of your company and we appreciate the trust companies place in our expertise. Emergo’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.