About Emergo Europe, official CE Authorized Representative
Emergo is an ISO-registered consulting firm with offices in the United States, Canada, Europe and Australia. By focusing on providing outstanding customer service and value for our clients, we have grown to become a leader in medical device regulatory affairs, including CE Mark Authorized Representative services, and quality system implementation, serving more than 700 medical device and IVD clients since 1997.
Why you should hire Emergo Europe
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 processes, and represent them to national authorities. We work hard to represent the interests of our clients and do everything possible to ensure that regulations are being followed.
Experience - We have helped more than 600 companies implement quality systems, or meet regulatory requirements. We are not a one person consultancy firm with knowledge limited to a few specialized products. Emergo consultants have diverse medical industry experience with a wide range of devices. Many 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 consultants that offer to help you meet regulations in Europe, Canada or Australia, but do not have staff there. Emergo has real people on the ground in all of these areas plus several offices in United States. That's important when regulatory issues arise that may require a personal visit with Competent Authorities or other entities.
Contacts - Emergo is well known in the 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.
Please contact us for a free consultation and no-obligation proposal on CE Authorized Representative services.
Emergo Europe is a member of the European Association of Authorised Representatives
