With 40+ years of experience in achieving successful Medical Device Regulatory Strategies, we are well placed to assist you to accomplish your objectives....
Please follow this link to see how we can help you ensure that your Technical Documentation meets all the Medical Device Directive requirements of the European CE Marking Medical Device Regulations MDD 93/42/EEC & MDR 2017/745 ....including Annex II and ANNEX III of the New MDR 2017/745.
Compliant Clinical Data is the single most demanding part of a Regulatory Strategy to accomplish; it is also the part of a submission where Notified Bodies raise most Major issues. All in all, ensuring that your Clinical Data is compliant, is fraught with pitfalls.......please follow this link to see how we can help give you the assurance that your Clinical Data is fully compliant with MEDDEV 2.7/1 rev 4.
Next to Clinical Evaluation Data, Post Market Issues is the second most important area against which Notified Bodies raise most points........Please follow this link to see how we can assist you to put in place compliant Post Sales / Post Market processes.
Bernard is seeking a Business Arrangement or Partnership, where a Company might benefit from his 40+ years of experience and form a mutually beneficial arrangement....Please follow this link if this is of interest to you.