Regulatory consultancy for medical devices
Alidans offers a complete regulatory consultancy service for the medical device sector, supporting companies in ensuring compliance with current regulations and obtaining the certifications necessary for the commercialization of their products. We collaborate with regulatory experts able to support our clients in all phases of the regulatory process, from initial design to post-marketing.
Services Offered:
• Definition of the regulatory strategy: we plan and implement customized strategies for the placing on the market of medical devices, taking into account the regulatory specificities of the target country.
• Consultancy on National and International regulations: we provide support to understand and comply with local and international regulations, including European regulations (MDR 2017/745, IVDR 2017/746).
• Drafting and updating technical Files: we ensure that all the necessary technical documentation is complete and compliant with the regulations, facilitating the CE marking process and other certifications.
• Class I, II, III Medical Device Consulting: we offer support for medical devices such as advanced dressings, active dressings, implantable devices and substance-based medical devices ensuring that they meet specific regulatory requirements.
• Patent consulting for Medical Devices: we provide specialized advice for the patent protection of medical devices, ensuring that the products are adequately protected from an intellectual property perspective.
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Personalized consultancy
Alidans also offers customized consulting services, tailoring solutions to the specific regulatory needs of each client. This approach allows us to address the unique challenges that each company faces in the Medical devices sector, providing specialist support to ensure commercial success and regulatory compliance.
Services Offered:
• FIM mechanism assessment: we have developed an in silico computational method to assess the pharmacological, immunological and metabolic mechanisms of medical device constituents, as well as ADME and/or in vitro tests. This process allows to identify and understand the interactions between device components and the human body.
• Chemical characterization of substances: we perform a detailed chemical characterization of medical device constituents and individual substances, assessing the individual or synergistic effects of the substances.
• Toxicological assessments: we conduct toxicological assessments based on the Threshold of Toxicological Concern (TTC) and on chronic and subchronic, acute and subacute toxicology studies, using in silico and experimental methods. We evaluate parameters such as NOAEL (No Observed Adverse Effect Level), LOAEL (Lowest Observed Adverse Effect Level), Ames test, mutagenicity tests, carcinogenicity, toxicity for reproduction.
• In vitro tests: we offer a complete range of in vitro tests to evaluate the biocompatibility, safety and efficacy of medical devices, in compliance with international guidelines (ISO 10993, ASTM, USP). We have developed tests to evaluate, for example, the barrier effect, the lubricant/anti-chafing effect. We collaborate with specialized laboratories to ensure the accurate and timely execution of these crucial tests, ensuring reliable results and compliant with current regulations.
• Clinical testing: we work with CRO (Contract Research Organization) to conduct clinical tests, demonstrating the efficacy of medical devices.
• Classification of substances in Medical Devices: we offer advice on the classification of substances used in medical devices both as functional substances and as excipients based on their function, such as flavorings, formulation antioxidants, barrier actives, lubricants.
• Supply of raw materials for Medical Devices: we supply excipients, flavorings, lubricants, refreshing/perfuming agents and other essential raw materials for the production of medical devices.
• Stability testing of Medical Devices: we work with laboratories capable of performing stability tests to ensure that medical devices maintain their efficacy and safety over time.
• Documentation drafting: we offer drafting services for ST, CoA, SDS documents for all substances used in medical devices.
• And other customized services: our range of services is constantly expanding to meet the dynamic needs of the medical device sector. We are ready to develop new customized solutions to meet the specific requests of our customers.
Alidans is the ideal partner to address regulatory challenges and ensure the commercial success of your medical devices. Contact us for a tailored consultation and discover how we can help you achieve your goals.
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