We provide a broad range of FDA compliance services to the Medical Device Industry.
mdi Consultants provides consulting services to the global healthcare industry, with proficiency in assisting medical device companies achieve compliance with Canadian, European and US regulations.
We recruit elite consultants with extensive industry knowledge who can offer insightful advice and provide high-quality services to clients.
We have highly defined systems and processes which are continuously refined across the ever-changing regulatory landscape. We also aim to stay ahead of policies through our participation in the regulations development.
Healthcare industry services
mdi offers an extensive range of services to the medical industry companies worldwide.
We have a proven track record of successful marketing authorisations for hundreds of US-based and international companies. Our expert advisers have a proven and flexible consulting methodology which offers our clients a customised service to meet their specific requirements.
Medical device companies’ assistance
We have been serving the medical device companies for over 40 years and have extensive experience in assisting businesses worldwide with entering and obtaining market approval in Canada, Europe and the US.
mdi provides clients with customised services in CE Mark approval, 510(k) and PMA submissions, current good manufacturing practice (cGMP) compliance, Medical Device Single Audit Program (MDSAP)and international organisation for standardisation (ISO) 13485 compliance.
Our medical device experience covers a vast array of product areas such as biologically based devices, contact lenses, gamma knives, peak flow meters, rehab equipment, as well as wheelchairs and scooters, oxygen concentrators, needles and MRI equipment.
Alongside these services, we also offer in-vitro diagnostic research and development and US Agent services for foreign companies.
Registering with the US Food and Drug Administration (FDA)
mdi enables businesses, including small companies and large corporations, to achieve compliance and supply Certificates of Registration to show adherence to FDA registration requirements.
We also offer authorisation of successful completion of the US FDA registration requirements.
mdi Consultants has been assisting businesses in successfully registering and complying with US FDA regulations for more than four decades. We guide businesses through FDA requirements to move their projects compliantly and efficiently through all applicable requirements.
US Agent services for foreign companies
For all businesses that do not have a physical establishment within the US, the FDA requires a US Agent. Foreign-based manufacturers will not be able to register facilities, list products or submit FDA marketing authorisation applications unless a US Agent has been designated.
All foreign manufacturers require contact information and identification when registering and listing with the FDA.
mdi Consultants represents numerous foreign-based businesses as their US Agent, fulfilling all responsibilities required under the law, as well as being a liaison between the FDA and the client company.
We help with all communications between the company and the Agency, including scheduling and negotiation of FDA inspections, as well as import detention issues.
About mdi Consultants
mdi Consultants is headquartered in Great Neck, NY close to New York City and has 11 representative locations across the world.
Our staff are experts in all FDA, Canadian and European compliance issues and include several former FDA investigators, ISO lead assessors and industry quality managers.
Mdi has been assisting companies worldwide to understand the FDA EUA (emergency use authorisation) for PPE devices (personal protective equipment).
The warning letters are the first to be distributed by the FDA for unapproved products meant to prevent or treat Covid-19, including unapproved drugs that pose significant risks to patient health and violate federal law.