Our Services for your market access
We provide you with comprehensive advice and support throughout the entire regulatory approval process for your medical device. Through our branches in the USA, United Kingdom and Brasil, we provide you with international access to important markets and are available as a neutral partner in these countries. With seminars and workshops, we offer support in your day-to-day business, from which you will benefit in the long term.
Analysis of the current situation and identification of possible improvements, presentation of the target process and support within the implementation of the necessary changes.
An Audit is the First Step...
No matter in which European or international market you are intending to market your medical device – we design, support or optimize your processes and ideas with our experience and expertise.
With Our Advice Through Audits
... in EuropE
In order to place a medical device on the European market, the manufacturer must undergo a conformity assessment procedure. This procedure confirms that
the manufacturer fulfills the organizational requirements to be allowed to place medical devices on the market and
the medical devices manufactured under such conditions meet the essential safety and performance requirements according to MDR (EU) 2017/745 and thus the CE mark may be applied.
An independent Certification Organisation and/or Notified Body carries out an audit with various focal points.
We support you in quality management, in your technical documentation and in all matters concerning the certification of your medical device on the European market.
... in USA
The FDA (Food and Drug Administration) is responsible for the approval and market surveillance of medical devices in the USA.
In the past an FDA inspection started with “Good morning, I’m your inspector – now let me see your complaints”.
Nowadays, FDA inspections are more focussed on processes and procedures than need to fulfill the current Quality System Regulations (21CFR820)- and beside that you still need to show inspectors your complaints….
We are happy to support you in the following activities:
- Registration of your company (Establishment Registration)
- Registration of products (Medical Device Listing)
- Submissions for medical devices (510(k) Premarket Notifications,
De-Novo Applications, PMA (Premarket Approvals))
- Preparation and successful execution of FDA inspections
... in the rest of the world
In order to harmonize international requirements, the Medical Device Single Audit Program (MDSAP) was introduced.
Based on the requirements of ISO 13485 supplement country specific requirements have been defined in seven processes.
With MDSAP certificates some of the routine inspections required by regulators in Australia, Canada, Brasil, Japan and USA, may be possibly waved.
We advise and support you in finding and closing gaps in your quality system and guide you through the audit of an accredited Auditing Organization.
Your Path to Certification
You have developed a new product and are now facing an audit? You are a contract manufacturer and are freshly setting up and want to implement a quality system?
MEDAGENT will guide you through the certification process and enable you to sell your medical devices on the market or provide high quality services to medical device manufacturers.
In a free preliminary discussion, we determine what your requirements are and clarify all necessary project steps with you in detail. We then compile a team that supports you directly on site and conducts an initial internal audit to analyze your compliance level and gaps. Based on these results, we work with you to improve existing processes so that economical, practice-oriented and standard-compliant procedures are implemented. We verify whether all objectives of the project have been achieved. This is followed by a post-audit review, which ensures that you are optimally prepared for the actual audit and receive your desired certification.
We accompany you through all steps to certification and are available to answer any questions you may have.
Free-of charge preliminary meeting
Process analysis and project planning
Implementation of actions and project monitoring
Successful external audit: Certification
We support you in all matters concerning the certification/approval and facilitate the market access for your medical devices.