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Regulations are often perceived as a burden and an obstacle on the way to CE and market access. We show you how to integrate regulation into your daily operations. We are convinced that every failure in the quality management system of a company can translate into death of a patient. Patient safety and risk based approaches are the basis of our daily work.
The new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have huge impact on the industry. We offer you strategic consulting to take important decisions, such as:
Which milestones do you have to reach until when to change to the new MDR?
How do you prepare your Technical Documentation to comply with the new MDR?
How can you allocate your resources best? Do you need interim support on specific topics?
What changes do you have to implement if you are a Private Label Manufacturer?
We also help you with the communication with authorities, Notified Bodies, Competent Authorities
and Expert Panels.
Specifically, for MedTech Start-Up Companies we offer following services:
establish a regulatory department
state-of-the-art Quality Management System (QMS) according to ISO 13485
Standard Operation Procedures (SOPs)
roadmap to the CE mark for the first medical device
selection of the Notified Body that best fits your requirements
for small companies: Responsible for Regulatory Compliance (MDR)
For established enterprises we offer:
support with Post Marketing Surveillance activities, such as complaint handling, customer feedback, CAPA handling, FDA medical device reporting and determination, EU vigilance
maintenance of Technical Documentations
continuous risk management
roadmaps for new CE certificates
For Private Label Manufacturer and Original Equipment Manufacturer:
Technical Documentation for OEM and PLM
check / development of Quality Agreements between OEM and PLM
Other services we offer:
classification statements for borderline products
internal audits (1st party audit) and supplier audits (2nd party audits)
support with external audits (3rd party audit)
state-of the-art clinical evaluation
due diligence for product acquisitions
regulatory input for new product development
early risk analysis
communication with authorities and investors
specialists for regulatory projects to relieve your team during work peaks
interim management, interim team lead
interim replacement for maternity and parental leaves