Emergo Group is an ISO registered medical device consulting firm with offices throughout North and South America, Europe, Middle East and Asia. By focusing on providing outstanding customer service and value for our clients, we have grown to become a leading medical device consultancy with expertise in regulatory affairs, quality system compliance, clinical trial consulting, in-country representation and medical device distribution.
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. 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 Group has worldwide offices in North America, South America, Europe, Asia and Australia. Therefore, we can support your regulatory needs in those geographic areas as you grow. We serve all sizes of medical device companies from startups and smaller growing companies to large multinationals.
Contacts - Emergo Group is well respected in the medical device consulting 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 path to compliance and achieve better results than might have otherwise occurred.
Our Mission - Our mission is to facilitate quality medical care worldwide by helping medical device manufacturers introduce products to global markets efficiently without compromising on compliance and safety for users and patients.