Germany
Service Provider
MAXCERT LTD
Germany
Maxcert is offering EC Representative services for non EU medical devices manufacturers. Maxcert is authorized/ registered EC REP service provider and can manage your ECREP requirements better than others. We make sure that you are MDR ready! and well updated with the EU regulations for your medical devices. Maxcert’s team has expert knowledge to help you navigate through the complex regulatory challenges that the new EU MDR 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. For more information, reach out to us at
MAXCERT LTD
Germany
Our experienced team has for years done documentation for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements. For manufacturers of medical devices / surgical instruments class I (including Is, Im, and new for MDR class Ir), IIa, and IIb we offer the following services: Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR Creating QM-Systems with procedural instructions and work instructions Technical Documentation Clinical evaluation Risk Management / Risk Analysis Essential Safety and Performance Requirements Validation of processes UDI-labeling Consulting for Regulatory Affairs Internal audits and external supplier audits Accompaniment and support with inspections by authorities and Audits by notified bodies Communication with authorities
MAXCERT LTD
Germany
The new European Commission’s guidance on persons responsible for regulatory compliance (PRRC) explains that manufacturers, Authorized Representatives and micro and small manufacturers must designate at least one staff member responsible for ensuring compliance to the MDR and/or IVDR as appropriate according to Article 15 of the Regulation. PRRC qualifications are specific for each of these three operators. This does not mean that you have to hire PRRC as employee rather you can avail our PRRC service to overcome the regualtory needs of your company and medical devices – with a consultant managing the system on a few days per month basis. We would be more than happy to discuss this option with you, helping you to find a consultant with the necessary qualifications to perform this service effectively. If you would like to know more about this service, then please contact us.
Maxcert can provide the strategic and technical guidance to develop an appropriate project plan, as well as assist with the implementation of any stage of the MDR certification process. QMS / Risk Management - Strategy for Regulatory Compliance - MDR-Specific QMS Changes - Classification & Conformity Assessment - Other EU MDR Directives & Regulations - Risk Management Evaluation Criteria - Benefit Risk Analysis - MDR Readiness Audits Clinical Evidence - Guidance on New Clinical Evidence Requirements - Legacy Product Data Review - Performance Evaluation Plan / Report (PEP/PER) - Analytical Performance Report - Clinical Performance Plan / Report - Clinical Performance Study Plan (CPSP) - Scientific Validity Report Labelling & UDI - Intended Purpose / Claim Review - Labels & Instructions for Use Requirements - Applicable Standards - UDI Requirements & Symbols Technical Documentation - Technical Documentation Review & Preparation - GSPR Gap Assessments & Traceability Matrices - Test, Hardware, Software Requirements Post-Market Surveillance / Vigilance - Post-Market Surveillance Plan / Report - Post-Market Follow-up (PMPF) Plan / Report - Incident Reporting - Periodic Safety Update Report (PSUR) Economic Operators / EUDAMED - Person Responsible for Regulatory Compliance (PRRC) - Registration of EO’s & Devices - Control of Suppliers (Process/Method) To speak to an MDR expert, or if you don’t see the services you are looking for, contact us
All non EU medical device manufacturers need an official authorized representative to continue selling their products in Europe. Do you want to be in EUDAMED ( European database for medical device )? Hurry Up otherwise you loose your customer and big market share!!
Service Provider
Heidelbergstr 79
69115 Walldorf - Germany
MPS MICRO PRECISION SYSTEMS AG
Switzerland
Novostia, a Swiss startup founded in 2017, has entrusted MPS with the manufacture of its TRIFLO artificial valve, a revolutionary aortic prosthesis on several levels. Thanks to its aerodynamic design, the presence of three leaflets and the absence of physical pivot axes for the leaflets, the TRIFLO valve aims to satisfy the following three criteria: - A device lifespan at least equal to that of the patient, to avoid the need for a second surgical procedure. This means more than 30 million flap openings and closures per year, with no leaks, blockages, cracks, ruptures or flap escapes. - The artificial valve must not lead to thrombosis, so that patients do not need to take anticoagulants. - Operation (flap opening and closing, blood flow through the valve) must be as silent as possible, so as not to disturb the patient or those around him, day or night. The TRIFLO device is in clinical trial and is not approved for sale.
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