SUMMARY OF SAFETY AND CLINICAL PERFORMANCE
At Hands on Research, we provide comprehensive SSCP services to help manufacturers of Class IIb implantable and Class III devices comply with EU MDR requirements and demonstrate the safety and clinical performance of their devices. Our services are aligned with the guidance provided by the Medical Device Coordination Group (MDCG) and are designed to meet the highest standards of quality and accuracy.
If you are a manufacturer of Class IIb implantable or Class III medical devices, you are required to prepare a Summary of Safety and Clinical Performance (SSCP) as part of your compliance with the European Medical Device Regulation (EU MDR). The SSCP provides an overview of the clinical data and performance of your device, and it must be included in your technical documentation and made available to the public.
We believe that creating an SSCP should not be a costly and burdensome process. Our cost-effective approach to SSCP preparation ensures that you receive high-quality services that meet regulatory requirements, without breaking the bank. By working with us, you can:
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Ensure compliance with EU MDR requirements and MDCG guidance for Class IIb implantable and Class III devices.
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Support the safety and clinical performance of your device.
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Provide transparency to regulatory authorities and the public.
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Get expert guidance and support throughout the SSCP process.
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Receive cost-effective services from a team of experienced professionals.
What we offer
Data Collection & Analysis
We collect and analyse relevant clinical data and performance information for your device, including data from clinical trials, post-market surveillance, and other sources. Our approach to data collection and analysis is based on the MDCG guidance document on SSCP (MDCG 2020-19)
Regulatory Support
We provide regulatory support throughout the SSCP process, including guidance on EU MDR requirements and MDCG guidance, assistance with technical documentation, and support for interactions with regulatory authorities. Our team of experts has a proven experience with the regulatory landscape and can provide valuable insights and guidance to help you achieve compliance.
Summary preparation
We prepare a clear, concise, and comprehensive summary of the safety and clinical performance of your device in accordance with EU MDR requirements and the MDCG guidance. Our summary includes all relevant information, such as the device description, indications for use, clinical investigation results, post-market clinical follow-up data, and more.
Committed to providing high-quality, reliable services.
Contact us today to learn more about our SSCP services and how we can help you achieve compliance and demonstrate the safety and clinical performance of your Class IIb implantable or Class III device, in line with MDCG guidance, while keeping costs in check.