This medical device CRO in Germany has built a strong reputation for high quality, excellent service delivery, and client orientation among an established client base across the EU over more than two decades. Its expertise in the stringent EU & German regulations for medical devices provide several avenues for revenue growth, from core clinical trial management for medical devices to scientific publication or Notified Body fees.
This CRO’s focus on the niche clinical trial market for medical devices accounted for profitable growth for well over a decade.
With the advent of the EU’s Medical Device Regulation 2017/745 (MDR) in 2017, the CRO expanded its PhD staff and moved to a larger location, in anticipation of business growth from new MDR business. A similar strategy for the German MPG Act had proved successful in earlier years.
Now that the investment in new PhD staff hiring and training has been completed, a new phase is unfolding with good prospects for strong, profitable growth. In this connection, the sole owner (an MD) made the decision to sell to another CRO or pharma consultancy industry firm, that can take this CRO to the next level. At the same time, the owner plans to stay behind during the transition period as a guarantee of orderly integration into a new group.
With the expected approval of its application for “Notified Body” (NB) authorization, a new source of consultancy revenue will be added later in 2021.
Potential synergies offered include complementary services in the profitable CRO niche for medical device trials; an established client base in Germany and the EU; and its well-trained PhD staff.
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This medical device CRO in Germany has a comprehensive clinical service offering, like trial management, clinical evaluation reports, MPG-compliant quality management or submissions to Ethics committees. Additionally, training services in these highly specialized domains is included in contracts with clients.
MDR-related services include:
• Support for:
o Post-market clinical follow-up (PMCF plan/report)
o Post-market surveillance (PMS plan/report)
o Summary of Safety and Clinical Performance (SSCP)
• Documentation preparation according to MDCG guidelines (Medical Device Coordination Group)
• Assistance in and evaluation of post-market clinical activities
• Consultancy and training
The above services cover medical devices like different types of implants, orthopedics products, wearables & medical apps in therapeutic areas ranging from nephrology, gynecology, dermatology or surgery, among many others.
Feel free to contact us for more information regarding this Medical Device CRO for sale in Germany. If you are looking for other pharmaceutical business for sale, please visit section pharmaceutical companies for sale. For a more pharma buyers please visit section pharmaceutical companies wanted.
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