The new MDR requires small to midsize medical device companies to take over the ‘Sponsor responsibilities’ for their clinical trials. Unfortunately for some companies, this may not be possible due to several reasons hindering this responsibility such as lack of:

• Scientific and Regulatory knowledge in clinical trials
• MDR and ISO14155 compliant Quality Management Systems (QMS)
• Manpower to keep sponsor oversight
• Clinical Trial Management Tools and Software solutions
• Experience in selecting the best Investigational study sites for their clinical trials
• Training in the clinical trial requirements of their staff, vendors, and study sites

GCP-Service would like to ensure that these hindrances do not lead to market exclusion of excellent medical devices. Therefore, we offer to take over the Sponsor responsibilities for companies for their clinical trials.

SpaaS®: What it means for your product

With this responsibility we work hard to prove the performance, safety, and benefit of medical devices/products to obtain market approval.

With more than 17 years of clinical trial experience, GCP-Service is happy to take over the responsibilities many organizations feel they are unable to do.

Our motto: When it comes to Regulator requirements, Patient’s Safety and rights, there is no longer room for Trial-and-error approach anymore. Our approach is to do it the right way the first time!

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