Medical Devices
We support manufacturers in drafting the complex technical documentation required to design, develop and market their devices. We also support the various economic operators in implementing a quality management system that complies with the relevant regulations. As ChemSafe, we are able to fulfil the role of Responsible Person for Regulatory Compliance
If you have any doubts regarding the regulation and the concerning guidelines/standards or how to implement them, our experts can help you.
Feasibility studies include:
A preliminary analysis of your product, does the MDR/IVDR apply? If not, what regulation does (i.e. Borderline Products)?
If the product falls within the scope of the regulation (MDR/IVDR), which classification rule applies?
Identification of the necessary steps to certify a new product, including individuation of the required tests.
The gap-analysis helps you to understand what kind of tests/analysis might be missing or need to be implemented (confronting old and recent versions of ISOs) to be compliant with the MDR/IVDR requirements.
Based on the new MDR requirements for substance-based medical devices, Chemsafe can provide you with an expert report able to exclude any pharmacological action of your ingredients.
All our pharmacological reports are verified and signed by an expert pharmacologist.
Is an important part of the Biological Evaluation Report, since it is a toxicological assessment of the individual chemical constituents used in the manufacturing process of your device. Mandatory for E&Ls (extractables and/or leachables) detected at levels of concern.
Toxicological Expert reports are also performed to verify the absence of toxicity related to the substances of which the medical device is made (case of medical devices substances-based).
All our toxicological expert reports are verified and signed by our ERT (European Registered Toxicologist).
The Biological evaluation is a crucial part of your risk management. This assessment consists of a biocompatibility evaluation based on the individual constituents and use of your device. Multiple aspects need to be addressed to successfully mitigate the biological risk.
BEP (Biological Evaluation Plan): The first step is a chemical characterization, then, based on the duration and nature of body contact, the required tests for your device are identified. The evaluation of all existing research data available (literature, the manufacturing processes, material specifications etc) is crucial for identifying the remaining biological risk and how to address it.
BER (Biological Evaluation Report): This report contains all the results obtained from your tests (chemical, biocompatibility), your toxicological risk assessment and other pertinent information gathered to support the safety of your product.
While Chemsafe has no internal laboratory, we can assist you during the testing phase thanks to our vast and versatile network and partnerships and monitor these studies.
The clinical evaluation serves to produce, collect, analyse and evaluate clinical data relating to your device in order to verify its safety and performance, including clinical benefits.
Chemsafe can support you in drafting the clinical evaluation plan (CEP) and report (CER) for your medical device, our services include:
- preparing a clinical development plan
- scope definition
- evaluation of your device according to the state of the art
- identification of appropriate data sources (systematic literature search, clinical trials, etc) and an adequacy assessment of these sources
- critical data analysis
- update of your clinical evaluation through data collection from post market activities
The purpose of Risk Management is to identify, evaluate, analyse and mitigate the potential risk of your product throughout its lifecycle. Chemsafe can support you during this process by providing you with a plan, identifying the risks and helping you to mitigate them, to ensure a proper risk/benefit ratio for your device.
Based on the information provided by the manufacturer and the preparation of the documents stated above (Annex II, III of MDR/IVDR), Chemsafe can review/prepare your Technical Documentation.
It is an essential requirement of the MDR/IVDR that the Manufacturer has an QMS in place, we can help you setting it up and evaluate how being compliant with other QMS might impact.
We can assume the role of Responsible Person for Regulatory Compliance for micro and small enterprises that shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.
Where the manufacturer of a device is extra-EU the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. We can assume the role of Authorised Representative for your products.