1st European Authorized Representative with 30 years of experience.
Market leader in EU, UK, Switzerland and in FSC.
Our team is well known for its expertise, excellent customer orientation and timely communication.
European and Swiss Authorized Representative, UK Responsible Person, U.S. Agent.
MDSS
MDSS is a leading Authorized Representative for Medical Devices, In Vitro Diagnostics Devices and Cosmetics with 30 years of experience!
MDSS specializes in European Regulatory Affairs and, as your Authorized Representative, MDSS offers you a first-class Authorized address in the EU, UK, Switzerland and US.
Chicago, Illinois (IL), United States
Healthcare
Products & Services
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About
Products & Services
U.S. Agent
MDSS
Your FDA US Agent must be a United States Resident or maintain a place of business within the United States. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours. Without a U.S. facility, you will be unable to register your facility, list your products, or submit the FDA marketing authorization applications without designating a U.S. Agent.
Swiss Authorized Representative
MDSS
A Swiss Authorised representative; “natural or legal person in Switzerland who has been mandated in writing by a manufacturer established in a foreign country to act on the manufacturer’s behalf in relation to specified tasks in accordance with Art. 4 para. 1 let. g from MedDO and with Art. 4 para. 1 let. f from IvDO."
As a Swiss Authorized Representative, MDSS CH GmbH is the main contact for the Swiss Authority. MDSS CH GmbH is responsible for the formal and safety-related issues connected with the placing of medical devices in the Swiss market.
We will guide you through the Swiss requirements ensuring you are in compliance with the Swiss Regulation.
European Authorized Representative
MDSS
The European Authorized Representative (EC REP) is a person or a legal entity who by designation of a manufacturer acts on their behalf. Your Authorized Representative is the main contact for the National Competent Authorities and performs certain duties under the European Medical Devices Regulations acting as the legal interface between you, the Medical Device manufacturer and the EU Authorities. An Authorized Representative may be addressed by authorities and bodies, instead of the manufacturer themselves, with regards to the requirements of the Medical Devices Regulations
Appointing MDSS as your EC REP will set your company on the forefront of European Regulatory Requirements. We meet the full EU criteria for CE marking and, most importantly, MDSS has long-term experience in Regulatory Affairs necessary to provide this demanding and `highly responsible´ Authorized Representative service!
UK Responsible Person
MDSS
The UK Responsible Person acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations... this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.
Our experienced team of Regulatory Affairs experts will guide you through the requirements of the MHRA (Medicines and Healthcare products Regulatory Agency).
About
As an Authorized Representative, MDSS is the main contact for the European Commission, National Competent Authorities, MHRA, Swissmedic and FDA.
Founded in 1994, MDSS pioneered European Representation, and is well known and respected with the Competent Authorities. As your Authorized Representative, MDSS handles sensitive tasks within the Competent Authorities with integrity and perfection, which enables us to achieve the best solutions for you.
Appointing MDSS as your EU and Swiss Authorized Representative, UK Responsible Person and U.S. Agent will effectively put your company on the forefront of Regulatory Requirements.
Through collaborative synergies among its offices, MDSS optimizes costs, forges powerful alliances and provides timely, comprehensive solutions for our client's protection, benefit, and corporate endurance, thereby distinguishing ourselves from our competitors.
Additionally, MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA) and Swiss Medtech.
We strive to provide the best representation in the ever-changing maze of European Regulations.
Founded in 1994, MDSS pioneered European Representation, and is well known and respected with the Competent Authorities. As your Authorized Representative, MDSS handles sensitive tasks within the Competent Authorities with integrity and perfection, which enables us to achieve the best solutions for you.
Appointing MDSS as your EU and Swiss Authorized Representative, UK Responsible Person and U.S. Agent will effectively put your company on the forefront of Regulatory Requirements.
Through collaborative synergies among its offices, MDSS optimizes costs, forges powerful alliances and provides timely, comprehensive solutions for our client's protection, benefit, and corporate endurance, thereby distinguishing ourselves from our competitors.
Additionally, MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA) and Swiss Medtech.
We strive to provide the best representation in the ever-changing maze of European Regulations.
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