Your Partner for Product Development and Market Access in Medical Technology.
We enable a hands-on approach to development and bring health innovation to the market.
We specialize in supporting clinical studies and research analysis.
Whether you’re a healthcare innovator or a medtech entrepreneur – we’re here to help you move forward!
Lorem Ipsum
Unsere Partner
WHAT WE OFFER
Our Solutions
Expertise
We bring product developers into the clinical setting early – enabling expert input and actionable feedback to set your innovation on the path to success.
Insights
We open the door to clinics. To give you access to clinical expertise, realistic test environments and clinical studies.
Regulation
We pave the way for approval. To ensure that this process runs for you as smoothly as possible, we offer advice and support on the way to the market.
Market Access
We will conquer new markets with you. We ensure that you are aware of all the options for financing your innovations and are networked with relevant stakeholders.
Learn from our success stories how we can support you too.
Kontakt
Was können wir für Sie tun?
Wir freuen uns auf Ihre Anfragen und den gemeinsamen Austausch. Was immer Sie in der Entwicklung Ihrer Medizintechnologie beschäftigt: Wir finden gemeinsam eine Lösung und setzten diese effektiv und effizient um!
ANY QUESTIONS?
FAQ
Industry-in-clinic platforms bridge the gaps between developers in medical technology and the medical expertise of clinics. And ensure smooth collaboration so that medical technology is supported by specialist staff from start to finish.
To integrate the existing high quality of medical expertise more extensively and precisely into the development of medical technology. This way, medical technology aligns better with medical care needs and actual day-to-day processes of clinics, specialist staff and patients.
An industry-in-clinic platform is a link between the medical technology industry and clinics. The industry benefits from rapid access to clinical feedback, optimized product development, direct exchange with healthcare professionals and efficient handling of studies. They also receive support with regulatory issues and quality management. Clinics not only benefit from easing the burden of regulatory issues and project management but also have the opportunity to participate in the development and testing of innovative products.
A clinical study is a scientific investigation in which a new medical device is tested on volunteers to assess the safety, efficacy and quality of the device.
In most cases, clinical studies are required to meet regulatory requirements and demonstrate the safety and efficacy of a product. However, exceptions may apply for low-risk products. Whether a clinical study is necessary and to what extent it must be conducted depends on the quality and quantity of clinical data already available. If the existing data is insufficient or of inferior quality, a clinical study is required. However, it is important to distinguish between two types of clinical studies according to the EU Medical Device Regulation (MDR):
– clinical study according to Article 62 of the MDR
The purpose of a clinical study is to assess the suitability of the intended purpose, the clinical benefit, the safety of the product and possible side effects.
– other clinical study according to Article 82 MDR
Another clinical study within the meaning of Article 82 MDR serves other purposes that do not fall under Article 62 MDR, such as basic research or feasibility studies.
Clinical monitoring is the process of overseeing a clinical study to ensure that it is conducted in accordance with the study protocol, its amendments, regulatory requirements and ethical standards. It ensures that data is recorded correctly and that patient safety is guaranteed at all times.
A sponsor is usually the company or organization that finances and initiates a clinical trial. The sponsor is responsible for planning, conducting and monitoring the study and for submitting it to the relevant regulatory authorities.
FastTrack MedTech offers comprehensive expertise in the field of clinical trials and medical technology. With many years of experience and flexible solutions, we are here to help you. Through our connection with Medical Valley EMN Association, we have access to a strong network in both industry and clinics to support you in the successful implementation of your projects. The process should be simple, precise and efficient.