ISO 13485 Consultants for Medical Device & IVD Companies

Emergo Group has specialized in helping medical device and IVD companies with quality system implementation and maintenance since 1997. As ISO 13485 consultants, one of our core specialties is helping manufacturers meet the quality system regulations for Europe, Canada, Japan, India, Brazil, Australia and other markets where ISO 13485 certification is the preferred (or required) method of meeting national regulations. We ONLY serve the medical device and IVD industry so ISO 13485 Quality Management System (QMS) compliance is not a sideline business for us, it’s our primary focus.

Which situation below best describes your company?

1. We are compliant with the US FDA regulations and now want to become ISO 13485:2003 compliant.

If you company is compliant with the FDA Quality System Regulations (QSR), you are half way to achieving ISO 13485 certification. Our ISO 13485 consultants will work with your team to seamlessly integrate ISO 13485 into your existing system to create a single quality system that meets US, European and Canadian (if desired) regulations. If you like, we can also make your quality system compliant with Japanese regulations at no additional cost.

2. We have operating procedures but no “official” quality system and want to implement ISO 13485.

If you are a small medical device company that has grown to the point of needing a formalized quality system, our experienced ISO 13485 consultants can help you achieve certification, typically in less than 6 months. Read more about how long it takes to get ISO 13485 certified. If you also plan to sell in the United States, we can make you fully compliant with FDA Quality System Regulations (21 CFR Part 820) at no additional cost.

3. We have no quality system in place and want to be compliant with ISO 13485 and/or FDA QSR.

New company? No procedures in place? No problem! We can typically have your company ready for your ISO 13485 certification audit by a Notified Body in about 4-7 months. We can customize the system to fit your needs by implementing ISO 13485 only or we can also make your company compliant with the US FDA QSR at the same time at no additional cost. Do you outsource manufacturing? Read our page on ISO 13485 for virtual manufacturers.

4. We have ISO 9001 certification but want to achieve ISO 13485 certification.

If your company is moving into the medical device industry and you need to become ISO 13485 compliant, we can easily help you accomplish this. Since you already have an established system of Standard Operating Procedures, our ISO 13485 consultants will examine your existing system and help you convert to ISO 13485 from ISO 9001, or show you how to maintain both certifications.

A single, integrated QMS that meets most international quality regulations…at no additional cost.

While there are many ISO 13485 consultants that can help you achieve certification, very few have knowledge of the specific international regulations of Canada, Japan or other countries that use ISO 13485 as a basis for meeting their QMS regulations but have additional requirements. Our ISO 13485 consultants are also experts in the FDA Quality System Regulations, Canadian Medical Device Regulations and Japanese PAL/Ordinance #169. Therefore, we are able to implement a single, integrated quality system that requires very little extra work for your team while meeting these international regulations AT NO ADDITIONAL COST TO YOU. Even if you have no immediate plans to expand into the Canadian or Japanese markets, for example, implementing a QMS that already meets their regulations will give you a head start when the time comes to expand your business into new markets.

Fixed fee pricing means no surprises.

We have implemented ISO 13485:2003 quality systems for so many medical device and IVD manufacturers that we know exactly how much time it will take. You can read more about the overall cost of ISO 13485 or how long it takes but rest assured that when you receive a proposal from us, it will clearly state the total cost of consulting fees and provide a detailed summary of how many days each step in the process will take us to complete.

We will help you obtain proposals for your ISO 13485 certification audit.

The Notified Body/Registrar you select for your certification audit is just as important as the ISO 13485 consultant you select to assist with implementation. Emergo Group works with most of the well known certification bodies such as BSI, Intertek, LNE/G-MED, TUV, UL and others so we can help you obtain proposals from these companies during the implementation process. Although we do not favor any one of these companies and recommend you receive proposals from 3-4 of them, some are better suited to handle specific types of manufacturers or devices than others. We have gained this practical experience first-hand working with hundreds of medical device companies over the years, and we share this knowledge with our clients during the implementation process. Read more about selecting an ISO 13485 certification body.

Please contact us for more information on how our ISO 13485 consultants can help you achieve certification.