ISO 13485 Quality Management Systems and Medical Device CE Certification Consultancy Services
From A to Z, we provide consultancy to Medical Device Manufacturers regarding any issue related to ISO 13485 Quality Management Systems and CE Certification processes
ISO 13485 and CE Certification
CE CERTIFICATION IN ACCORDANCE WITH 2017/745/EU MDR REGULATION
If you consider producing a medical device or have it produced, or if you have already produced a medical device and would like to acquire the ISO 13485 Quality Management System certificate and the CE certificate appropriate to 2017/745/EU (MDR) Medical Device Regulation, with our sector experience gained from more than 150 Medical Device Manufacturers and more than 250 Medical Devices, which we fit into our 15-year history and whose certification process has been completed, we would be glad to offer our services, which is only and only the Training and Consultancy services in the ISO 13485 and CE Certification processes for Medical Device Manufacturers.
Conformed Training and Consulting Services
OUR SERVICES
As Conformed, we provide end-to-end training and consultancy services for medical device manufacturers in MDR, ISO 13485, and CE certification processes. We support manufacturers at every stage, from product classification to MDR Technical Documentation preparation, from ISO 13485 Quality Management System setup to Clinical Evaluation and Validation processes, with our expert team. Our goal is to facilitate medical device manufacturers’ safe and compliant access to national and international markets.
Are you planning to manufacture or have a medical device manufactured, or have a medical device manufactured, do you need an ISO 13485 Quality Management System Certificate and a CE Certificate in accordance with the 2017/745/EU (MDR) Medical Device Regulation?
ISO 13485 and CE Certification
Conformed Training and Consulting Services
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+90 544 937 82 53
+90 544 937 82 53
USEFUL INFORMATION
What is the 2017/745/EEC Medical Device Regulation (MDR)?
Introduction The MDR (Medical Device Regulation 2017/745/EU) is a new regulatory framework established by the European Union for medical devices. This regulation introduces comprehensive rules and requirements aimed at enhancing the safety and effectiveness [...]
WHAT IS MEDICAL DEVICE CE MARKING AND CE CERTIFICATION?
In order for Medical Device Manufacturers to obtain the right to free movement in the European Market, it is necessary to demonstrate compliance with European Standards, in the simplest terms. This compliance is represented [...]
WHAT IS ISO 13485 CERTIFICATE?
What is ISO 13485 Certificate? ISO 13485 is a Quality Management System standard specifically for medical device manufacturers. This standard defines the requirements for a quality management system (QMS) that covers the entire process [...]