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Medical device design
LVL Mediphar helps you through your medical device design from the early start until market launch.
Guidance to medical device CE marking and the implementation of the European MDD 92/43 EC and ISO 13485 quality management system.
Experience in several projects: from idea, early design input and risk analysis implementation, search in the right subcontractors & manufacturers, usability requirements, through help in device classification and design verification with additionnal partners and final device validation.
We also have practical approach experiences in class I, class IIA (sterile disposables), IIb and class III in several clinical areas like cardio surgery and cardiology, wound management, drug delivery, gynecology, etc…
Medical device follow up
Your partner in establishing a working post marketing surveillance program. From literature study, complaint and incident management and report documentation. Check up and audit review of your technical documentation file in order to stay current at the latest regulatory compliance, at new and/or revised harmonized and vertical norms and state of the art. Review and helping you in the practical approach for risk planning and risk management compliance following ISO 14971 and risk management tools like FMEA, TFA, HACCP, etc.
Technical documentation file
Redaction of full technical documentation file following the latest Meddev and GHTF guidelines and regulatory requirements. Review and writing of technical brochures, instruction for use and label programs. Assistance in notified body selection and preparation for the conformity assessment route for CE marking and notification. Post marketing and clinical evaluation assistance and bibliographic search to stay current with the new requirements on clinical evaluation of medical devices.