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Medical device design
LVL Mediphar helps you through your medical device design from the early start until market launch.
This includes guidance to medical device CE marking and the implementation of the European MDD 92/43 EC and ISO 13485 quality management system.
We have extensive experience across a wide range of 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 additional 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, gynaecology, etc.
Medical device follow up
We are your partner in establishing a working post-marketing surveillance program. From literature study, complaint and incident management to report documentation. Check-up and audit review of your technical documentation file in order to stay up-to-date with the latest regulatory compliance, at new and/or revised harmonized and vertical norms. We help you with reviewing 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. We act as a quality manager and will save you considerable time in the long run.
Technical documentation file
Editing 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 up-to-date with the new requirements on clinical evaluation of medical devices.