Makrocare invites you to join us at the MedTech Summit 2018 organized by KNect Life Sciences, a unique event dedicated to the European MedTech ecosystem, to be held on 11-15 June 2018 in Brussels, Belgium.
EU adopted the new Medical Devices Regulation; it will enter into force after a transition period ending in spring 2020. EU MDR regulation consists of multiple areas. While you may be well positioned in some of the areas, most companies are projected to fall short on the resourcing and right expertise as MDR needs a diverse experience in different areas.
MakroCare MedTech center of excellence (COE) supports companies in 3 areas:
Clinical Evidence/Performance/Benefit (Current clinical data Gap analysis, Setup Data Collection/Analysis Programs, Run Registry or Retrospective Programs for your current devices, Data Acquisition, Utilize our Proprietary IT technology, Analysis/Statistics, Literature Search and Medical/Scientific Writing)
PMS (setup PMCF, Vigilance and PSUR Aggregate Reporting)
UDI (Setup digitization process, collect data points, align IFU to UDI, provide UDI technology and Eudamed setup assistance)
Benefits with MakroCare:
Dedicated teams who understand your devices for your MDR compliance
Therapeutic Area experts to provide holistic clinical depth
Direct time & cost efficiencies using us
Position your products better to face NB audits
Avoid last-minute rush and not pay premium costs for resources /companies
MakroCare is ISO 14155 certified (clinical investigation for medical devices) & ISO 9001
MakroCare for 15+ years has been successfully helping many Pharma, Biotech and Medical Device companies right from designing their Regulatory Strategy to getting product approvals globally. Our experts are connected to deliver integrated services across North America, Europe, and ROW with detailed knowledge of different local submission processes.
Will you be at MedTech Conference? Set up a time to meet with us!