Regulatory, Clinical and Business Consultancy for Medical Devices
Full Service. Dedicated for MedTech
We provide Regulatory, Clinical and Business consultancy services in the MedTech Industry. At MD squared, we believe that we are in a unique position to support our customers in bringing meaningful MedTech Innovations to patients in time. We can do this because, in addition to our subject matter expertise, we vigorously pursue a multi-disciplinary approach.
Seasoned professionals in MedTech
We are a team of international experts in Medical Devices helping you to start, assess, improve and grow your medical device business. A We have experience in the fields of Regulatory, Quality, Clinical, Research & Development, Business strategy, Marketing & Sales. Our expertise in these relevant areas is at your service for taking the right steps to grow your business.
Our concept
We support MedTech companies through various phases of development and commercialization.
We apply multidisciplenary knowledge to establish the meaningfulness of a MedTech innovation in a specific context of use. We help our clients to understand timelines and costs for the journey towards market access in selected key markets.
PathFinderTM
Seeking an expert for your regulatory strategy, clinical study design or technical realization of your innovation?
We aim to guide founders & CEOs through the early phases of the company. In our PathFinder program, our multidisciplinary team provides a structured assessment to identify steps and choices towards market access for medical devices.
By means of reviewing the product of a company in the context of all major disciplines, together we lay down the foundation and roadmap to get the devices successfully on the market. Aspects such as the regulatory pathway, target market (indication), clinical development plan and study design are reviewed. Critical interdependencies are flagged and discussed to get a full picture of the strategy going forward.
See PathFinder for more information
Voyager
After planning and identification of the crucial steps towards the market, the realization of the milestones is needed.
During our Voyager program, we offer clients tailored support in their technical-, clinical- and regulatory matters. We aim to do this by coaching our clients using a hands-on approach: guiding them through the relevant decisions and helping them write the required documents.
See Voyager for more information
Other Services
Seeking for a partner for internal audits or do you require additional support during your process with stakeholders such as Key Opinion Leaders, the FDA or a Notified Body? MD squared its experts can fulfil specialized work to accelerate your company’s operational activities or be involved in Mitigation and Remediation.
See Other Services for more information.
