About Emergo Group
Emergo Group is an ISO registered medical device consulting firm with offices in the United States, Canada, Europe, 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 CE Marking, Good Manufacturing Practices (GMP), ISO 13485 quality system implementation, Canadian licensing, China SFDA registration, Japanese device approval, in-country representation and many other areas.
- Meet our consulting and management team
- Testimonials from clients
- See our ISO registration certificate
Why you should select Emergo Group as your medical device consultants
Integrity - We advise clients so their business can grow. 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 inform you accordingly.
Responsibility - Clients place their trust in us to guide them through complicated regulatory processes, and represent them to governmental 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 met.
Experience - We have assisted hundreds of companies with implementing quality management systems or meeting international regulations for the USA, Europe, Canada, Japan, China and Australia. We are not a one person consultancy firm with knowledge limited to a few specialized products or areas. We are a medical device consulting firm with diverse experience with a wide range of devices and disciplines. Many of our consultants are Certified Lead Assessors and experienced regulatory affairs professionals who have been involved in developing, implementing, training and auditing organizations to numerous ISO standards and regulatory requirements.
Reach - Emergo has offices in Europe, United States, Japan, China, Australia and Canada. Therefore, we can support your regulatory needs in those areas.
Contacts - Emergo Group is well respected in the medical device regulatory industry and stays active in several associations and technical committees. 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 expedite your road to compliance and achieve better results than might have otherwise occurred.
Service - We take pride in the fact that a significant portion of our business comes from existing clients.
