Privacy Settings

Language Selector. Press to change the Cookie Notice language.

When you visit any web site, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience.

Disable All

Enable All

Manage Consent Preferences

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Show Cookies

Name

Description

Analytics Cookies (Matomo)

Matomo is an analytics software used by this Website to analyze data directly without the help of third parties.
Personal Data processed: IP address, Trackers and Usage Data.
Legal basis for processing: Consent.
Legal basis for data transfer: No data transfer.
Storage duration:
_pk_id*: 13 month
_pk_ses*: 30 minutes

Show Cookies

Name

Description

Cancel

Save & Close

About MDSS Consulting GmbH

MDSS Consulting GmbH

Your Partner for Medical Device Registration

MDSS Consulting GmbH consists of a qualified team with various educational backgrounds (e.g. medical engineering, biology). Our employees have extensive expertise in the field of medical devices.

We support manufacturers, Authorized Representatives and other economic operators in regards to the requirements of standards which apply to them.

We guide you all the way from delimiting your product against other product types, through classifications of medical devices / IVDs, to clinical evaluations. Our daily challenges include creation of technical documentations and various tasks in the quality management area – up to advising with regulatory questions concerning development, manufacturing and placing on the market of medical devices worldwide.

Furthermore, our service includes carrying out internal audits and training, as well as assistance with external audits and authority inspections.

Our area of activity at a glance

Medical Device Regulation (EU) 2017/745
In-vitro-Diagnostics Regulation (EU) 2017/746
other European Directives & Regulations (ROHS, PPE, etc.)

Our Services

Quality Management
Regulatory Affairs
Clinical Evaluation

This includes, among others:

We support you all the way, from delimiting your product against other product types, through classifications of medical devices / IVDs, to clinical evaluations / performance evaluations. Our daily challenges include creation of technical documentations and various tasks in the quality management area – up to support with regulatory questions concerning development, manufacturing and placing on the market of medical devices worldwide.

Furthermore, our service includes carrying out internal audits and support with external audits and authority inspections.

MDSS Consulting GmbH offers both precise emergency assistance and long term consulting projects.