About Emergo Group
Emergo Group is an ISO registered medical device consulting firm with offices in the United States, Canada, Mexico, France, Netherlands, China, Japan and Australia. By focusing on providing outstanding customer service and value for our clients, we have grown to become one of the leading medical device regulatory consultants with expertise in FDA 510(k) submissions, CE Marking, Good Manufacturing Practices (GMP), ISO 13485 quality system implementation and many other areas. Read about why you should hire Emergo Group for your 510(k) submission.
Service – We take pride in the fact that 90% of our clients return to us for additional work year after year, a testament to the high quality of service we provide.
Integrity – We advise clients so their business can grow, not confuse them for personal gain. We never propose more work than is absolutely necessary, and charge a fair fee to complete that work. If we do not feel we are qualified to do a project, or we feel there is a less expensive alternative, we will tell you up front.
Responsibility – Clients place their trust in us to guide them through complicated regulatory processes, and represent them to national authorities. We work hard to represent the interests of our clients and do everything possible to ensure that medical device and IVD regulations are being followed.
Experience – We have helped more than 1,000 companies implement Good Manufacturing Practices (GMP), ISO 13485 quality systems, submit 510(k) applications or meet other international regulatory requirements. We are not a one person consultancy firm with knowledge limited to a few specialized products. We are a medical device consulting firm with diverse experience with a wide range of devices. Many of our consultants are Certified Lead Auditors who have been involved in developing, implementing, training and auditing organizations to numerous ISO standards including ISO 9001, ISO 13485 and ISO 14971.
Reach – Beware of medical device regulatory consultants that offer to help you meet regulations in Europe, Canada, China, Japan or Australia, but do not have people there. Emergo has offices in all of these areas in addition to our US headquarters. That’s important when regulatory issues arise that may require a personal contact.
Contacts – Emergo Group is well known in the medical device regulatory industry and stays active in several associations. Over the years, we have made numerous contacts within government agencies, testing labs, associations and others allied with the field. As a result, we can often make things happen faster, less expensively or with better results than might have otherwise occurred.
