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Catalogue of Services

From Strategic Consultancy to the Planning and Execution of Clinical Trials

Strategieentwicklung und Beratung

Workshops für individuelle Studienlösungen und Unsicherheitsbeseitigung.

Study design

Creation of study concepts and consulting on digital study elements.

Performance of Clinical Studies

Training, study monitoring and close collaboration with study centers.

DDCT-MED®

Digital Decentralised Clinical Trials in the MEDIACC

Biomedical Statistics and Clinical Outcome Evaluation

From initial data to convincing results for your medical device

Publications and Medical Writing

Data analysis, study reports, and support for professional publications.

Trainings and Seminars

Practical knowledge transfer for your success

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StrategIC development for YOUR clinical trial

The cornerstone for your successful health innovation

Strategic development is the first step in ensuring the success of your medical device or digital health application. Utilise our market knowledge to establish the appropriate evidence base for your product and let us collaboratively develop bespoke solutions in a workshop setting.

Arrange an initial consultation

Together, we develop your strategy for success

We show you ways to be successful on the market with your product. Our advice starts with the design of your clinical strategy, guides you through regulatory requirements and only ends when your product is successfully established on the market. In doing so, we see ourselves as a partner who makes your goals our own.

With in-depth expertise for all phases of product development, we are your reliable partner for all questions relating to clinical evidence for your medical device. We support medical device companies and start-ups from initial idea to market entry and beyond.

  • Approval of your medical device in Europe
  • Approval of your in vitro diagnostic device in Europe
  • Continuous evaluation of the safety, performance and effectiveness of the medical device
  • Inclusion in the German Medical Technical Aids Register
  • Inclusion in the German Care Products Register
  • Recognition and reimbursement as DiGA (Digital Health Application)
  • Fulfilment of regulatory requirements
  • Knowledge regarding off-label use of the medical device
  • Reimbursement by statutory and private health insurance companies
  • Assessment of the risk/benefit ratio
  • Extension/ Amendment of indication/ intended purpose
  • Competitive advantage

Our services — your success

Rely on our extensive experience in planning, carrying out and evaluating clinical trials and evaluations — from scientific literature work to multi-center, completely digital RCT.

MEDIACC accompanies you through all phases with individual strategies and practical implementation so that you can safely meet regulatory requirements and prove the medical benefits of your innovations.

With many years of experience, we support you in all tasks that medical device manufacturers need for clinical evaluations and clinical follow-up derived from Annex XIV of the new EU Medical Devices Regulation (EU MDR 2017/745).

We offer you full service before placing on the market of your medical device, when planning the clinical evaluation, subsequent implementation and documentation. We also help you generate clinical evidence after placing on the market in accordance with the appropriate regulations.

  • Approval studies/conformity assessment procedures
  • Clinical reviews
  • Proof of benefit for CE-certified medical devices within or outside the intended use, with or without additional burdensome or invasive measures
  • Post-market clinical follow-up (PMCF)
  • Post-market performance follow-up (PMPF)
  • Pilot studies
  • Systematic literature searches
  • Purely scientific studies, in which medical devices may also play a role
  • Multi- or monocenter, randomized controlled prospective clinical trials

Our consulting services

Benefit from our in-depth consulting expertise in clinical research as well as evidence-driven approval and reimbursement of innovative medical devices. MEDIACC supports you in developing sustainable strategies, selecting optimal study designs and efficiently using and evaluating existing data for targeted and economic evidence generation.

  • Strategy development
  • Regulatory advice
  • Development of a suitable study design for generating evidence in accordance with applicable regulations with verification of the suitability of existing data:
    • Retrospective analyses
    • Systematic data evaluations
    • Application observations
    • Case series
    • Case control studies, historical control studies
  • Budget estimates

We advise you and supervise clinical trials in accordance with the following regulations and guidelines

Rely on our expertise in dealing with all relevant regulatory requirements and guidelines. MEDIACC safely navigates you through the interplay of MDR, IVDR, national laws, established international norms and standards — so that your clinical investigations (trials) and evaluations are carried out in a legally compliant manner at all times and are recognised by authorities and experts.

  • Medical Device Regulation (MDR), Art.62 – 80
  • Medical Device Regulation (MDR), Art. 74
  • Medical Device Regulation (MDR), Art. 82
  • In Vitro Diagnostic Medical Devices Regulation (IVDR), Art. 58
  • In Vitro Diagnostic Medical Devices Regulation (IVDR), Art. 70
  • Medical Device Law Implementation Act (MPDG)
  • Legal provision for the Medical Devices Act (national Austria)
  • UK Medical Devices Regulations
  • DIN EN ISO 14155:2021-05
  • Professional Code for Physicians (BO-AE)
  • General Data Protection Regulation (GDPR)
  • Declaration of Helsinki
  • Good Clinical Practice (GCP)
  • Good Epidemiological Practice
  • New examination and treatment methods in German Statutory Health Insurance (GKV) in accordance with §137e SGBV (NUB procedure)
  • Medical Device Coordination Group (MDCG): current guidelines

We advise, design, plan and conduct clinical investigations (trials) in the following specialist areas:

Thanks to our many years of experience and our interdisciplinary team, we provide you with competent support in a wide range of medical fields. With individual advice, up-to-date expertise and a partnership-based approach, MEDIACC supports your projects — from internal medicine to psychosomatics and neurology to highly specialized indications.

  • Internal Medicine (Cardiology, Pulmonology, Gastroenterology, Hematology and Oncology, Angiology, Immunology)
  • Psychosomatics (sleep disorders, pain, concentration)
  • Psychology
  • Addictive disorders
  • Obesity
  • Orthopedics
  • Traumatology
  • Sports medicine
  • Neurology
  • Paediatrics
  • Urology, andrology
  • Intensive care
  • Radiology
  • Gynecology, pregnancy problems
  • Surgery
  • Ophthalmology
  • Dermatology

We support you with various product categories

As a manufacturer of innovative medical devices, you face a wide range of regulatory and scientific challenges — regardless of product category or level of innovation. Based on many years of experience, we provide you with targeted support in generating clinical evidence for your various products.

  • Medical devices in risk classes I, IIa, IIb and III
  • In vitro diagnostics
  • Naturopathy procedures, Dietary Supplements, Probiotics
  • Care products
  • Technologies or medical devices that use artificial intelligence (AI)
From evidence to market-wide acceptance

What distinguishes us from classic pharmaceutical CROs:

Many CROs come from the pharmaceutical world. Not us. We have specialised in medical devices right from the start. Why is that important to you?

At MEDIACC, we rely on an adaptive, individual consulting approach using many years of specialised experience, so that you can only guess at our established standard processes that have been tried and tested by reality.

We feel comfortable with the diversity of medical devices, the indications and the people behind these products. In doing so, we always keep the benefits, the safety and dignity of our patients at the centre of attention.

Our approach comes directly from medical device regulations and is part of our DNA. In doing so, we avoid anything that does not belong in the pharmaceutical sector and develop lean studies for your products.

Before we design new studies for you, we will work with you to determine whether there is already data about your products, from which data can be derived for your purpose and which has already been recognised by authorities, health insurance companies, investors, service providers or professional associations.

MEDIACC clearly stands out from classic CROs through digital expertise, tailor-made and holistic advice, a focus on medical benefits and reimbursability, and many years of experience in the area of medical devices.

We develop tailor-made solutions for you that exactly meet the regulatory requirements of your specific medical device and help you achieve your goals faster and economically.

Contact us today for a personalised consultation!

From data preparation to statistical analysis - our experienced team of scientists and analysts will support you in your next research project. Trust in our expertise and let us find the answers you are looking for together.

Arrange a free consultation now
address:
Sächsische Strasse 70
10707 Berlin Wilmersdorf
Germany


contact:
030 521 044 80
info (at) mediacc.de
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