Portfolio
Portfolio
EU Representative
... Taking over the function of the EU representative With our service we offer you the assumption of the EU authorized representative (EU-Rep) with all associated obligations or parts thereof. Article 11 MDR/IVDR: „Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorized representative.”
CE Marking & EU Approval
... Approval of medical devices and IVD (CE marking) On your request we will identify the regulatory needs and provide solutions in order to achieve the CE-mark for your device. In full-service or part-service only.
International registrations
... Registrations outside Europe. If you are planning to enter to international markets outside the EU we would like to assist you with planning and execution.
Technical file according to MDR & IVDR
... Establishment and maintenance of the technical file according to MDR and IVDR The current EU-regulations rise extensive requirements to the manufacturer and the technical documentation. We will enable you to perform accordingly to effective and efficient manner.
MDR & IVDR-Compliance
... General MDR & IVDR Compliance Preparation and documentation of processes in compliance to MDR and IVDR. As well as upgrade and actualization of existing processes and documentation.
Quality Management System
... Establishment and maintenance of a quality management system based on ISO 13485, 21CFR820 and MDSAP. Lean and effective processes and documentation does pave the way to your success and certificate(s).
Audits & Inspections
... Internal and external audits. We take care of the preparation and execution of your audits and inspections. Inclusive planning, execution and reporting.
Supplier management
... Supplier qualification and management We support you in systematic supplier-management and qualification of new suppliers.
Computer System Validation
... Computer system validation CSV. Management, planning and execution of computer system and process software validation
Person Responsible for Regulatory Compliance acc. to Article 15
... Regulatory Responsible Person We take responsibility of the function as regulatory responsible person acc. to MDR/IVDR article 15 "Person Responsible for Regulatory Compliance”
QMR Quality Management Representative
... We take responsibility of the function as quality management representative.
Development of company departments
... Support of the customer in setting up own departments for the activities listed here.