Medical Devices Regulatory Consulting Specialists Since 1997
Emergo Group is an ISO registered medical device consulting firm with offices in the United States, Canada, Europe, China 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 CE Marking, Good Manufacturing Practices (GMP), ISO 13485 quality system implementation, Canadian licensing, China SFDA registration and many other areas.
Meet our team
Read what our clients have to say about us
View our affiliations with industry and community organizations
View a copy of our ISO registration certificate
View a copy of our IRS W-9 Form
Why you should work with Emergo Group
Service - We take pride in the fact that 95% 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 hundreds of companies implement Good Manufacturing Practices (GMP), ISO 13485 quality systems, or meet other regulatory requirements such as CE Marking. 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 Assessors 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 who offer to help you meet regulations in Europe, China, Canada or Australia, but do not have people there. Emergo has real people on the ground in all of these areas. That’s important when regulatory issues arise that may require a personal visit with Ministries of Health or other entities.
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 associated with the industry. As a result, we can often make things happen faster, less expensively or with better results than might have otherwise occurred.
