Regulatory Services for Medical Devices
Any medical device must be evaluated for its biological hazards, risk characterization and toxicological risk assessment to ensure the safety for the consumer and regulatory compliance depending on varying international marketplaces and geographies.
At QACS Lab, we offer a range of biological and toxicological safety evaluation assessments to ensure your medical device is safe and regulatory compliant, while focusing on the most efficient means possible to complete necessary tests.
Classification of Medical Device
The MDR describes the classification of medical devices, which in principle is based on the intended purpose, nature of medical device associated with the risks of the product.
Instructions For Use
The “Instructions for use (IFU)” is an essential part of the technical documentation of a medical device and thus of the conformity assessment procedure.
Biological Evaluation Plan
This is the first step of the biological evaluation for all medical devices. The Biological Evaluation Plan summarizes and characterizes a medical device based on its nature, components and way of use. It also identifies potential biocompatibility gaps and endpoints of concern. Therefore, the added value of performing it is not only to comply with the MDR, but also to better understand your device and avoid potential gaps that might be time-consuming in the developing and submission process.
Toxicological Risk Assessment
The Toxicological Risk Assessment evaluates the toxicity of individual components of the formulation used to produce a medical device and determines any mitigation strategy to ensure the safety of the medical device following the ISO 10993-1
Biological Evaluation Report
The Regulatory team of QACS Lab builds a comprehensive technical document providing the assessment of the medical device’s biological safety as per ISO 10993 and ISO 14971. It is based on the Biological Evaluation Plan and Biocompatibility data, while it is part of the technical file for the regulatory submission and later approval of your medical device.
Clinical Evaluation Report
The Regulatory team of QACS Lab builds a comprehensive technical document providing the assessment of the medical device’s clinical safety as per ISO 10993 and ISO 14971. It is based on the Clinical Evaluation Plan and Clinical data, while it is part of the technical file for the regulatory submission and later approval of your medical device.
National registration
At QACS Lab we can assist you with the registration of the manufacturers and their nationally authorized medical devices (Greece and Cyprus).