Medical device consultancy
From medical device design to CE-marked market launch and post-market follow-up.
With over 20 years of experience in pharmaceutical GMP/GDP compliance and medical device regulatory affairs, LVL Mediphar supports manufacturers throughout the full device lifecycle — from concept and development to approval and ongoing compliance.
Medical device
Design
LVL Mediphar supports medical device development from early concept to market launch. We provide practical guidance on CE marking, compliance with the European MDD 93/42/EEC, and implementation of the European Medical device regulation (MDR ) EU 2017/745.
We assist with early design input, risk management, subcontractor and manufacturer selection, usability requirements, device classification, verification, and final validation—working with trusted partners when needed.
Our experience spans Class I, IIa (incl. sterile disposables), IIb and Class III devices across clinical areas such as cardiology, cardio surgery, wound management, drug delivery and gynaecology.
Medical device
Follow up
We support you in establishing and maintaining an effective post-market surveillance program. This includes literature reviews, complaint and incident management, and preparation of required reports.
We also perform reviews and audits of your technical documentation to ensure ongoing compliance with the latest regulatory requirements, including updated harmonized and vertical standards.
In addition, we provide practical support for risk planning and risk management in accordance with ISO 14971, using tools such as FMEA, FTA and HACCP. Acting as your quality management partner, we help streamline processes and save you valuable time in the long run.
Medical device
Technical
documentation file
Editing of full technical documentation file following the latest MDCG and IMDRF guidelines.
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.
Contact
LVL Mediphar bvba
Scheurestraat 7
9850 Landegem, Belgium
BE 0862 946 642
+32 475 37 78 43
lieven@lvlmediphar.be