EU Regulatory and Quality consulting firm focused on Medical Devices & Diagnostics
Maxcert’s team has expert knowledge to help you navigate through the complex regulatory challenges that the new EUMDR bring. We can assist you through out the entire process to ensure that you and your business are compliant with all of the EU-MDR requirements.
MDR DOCUMENTATION
Guidance, Templets & Support to ensure Technical Documentation Complies with EU Medical Device Regulation 2017/745
EUDAMED & UDI GUIDE
SRN & Registration of devices / UDI and Traceability EUDAMED Guidance on UDI for systems and procedure packs
PRRC SERVICES PACKAGE
Person Responsible for Regulatory Compliance, You must not hire a regulatory employee as an SME, BOOK our PRRC !!
CLINICAL INVESTIGATION & EVALUATION
CER, Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745. Post-market clinical follow-up (PMCF) Evaluation Report
EU & UK AUTHORIZED REPRESENTATIVES
We are officially authorized to act as your Representative in EU & UK.
SURVEILLANCE & VIGILANCE
Serious Incidents requirements & reporting to competent authorities
RISK MANAGEMENT
Risk management Plan, Assessment & Review for medical devices and the new EN ISO 14971
QUALITY & REGULATORY Audits Support,
Free Sale Certificates from European Authorities and MHRA
Maxcert’s medical device expertise also includes on-shore, region specific submission support and global regulatory consulting & intelligence:
- US: Pre-Market Authorization (510(k) application process support), Premarket Approval (PMA), UDI Services.
- Europe: ECREP Services, PRRC, Technical File Preparation & Submission, CER Writing & Updating, EU MDR Consulting & Gap Analysis, Post Market Surveillance Plans & Reports
- UK: UKRP, other Technical/ consulting support
- Emerging Countries: Country-Specific Submissions.
- Interpretations of local requirements including Medical Device Classifications, licensing, registrations and renewals.
- Regulatory strategy consulting, including reports on country-specific updates to Regulatory requirements.
- EU MDR Consulting.
Our clients
Medical Devices Manufacturers developing a first major product navigating into the different steps of development or reaching the registration phase.
Medical Devices Manufacturers looking to introduce their first product on the EU Market and possibly accelerate via early access paths.
Medical Devices Manufacturers looking to ensure regulatory compliance during the commercialization of their products.