ISO 13485 Quality Management Systems and Medical Device CE Certification

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

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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.

STEP 1

 

Product Classification by determining the intended use, place of use, life cycle and the content of the Medical Device

STEP 2

 

Revealing the product prototype to complete the Medical Device Design

STEP 3

 

ISO 13485 Quality Management System Installation and Formation of CE Technical Files

STEP 4

 

Completion of Notified Body Audits

STEP 5

Completion of Product Tracking System (ÜTS) Company and Product Registration

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OUR SERVICES

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 Quality Management System

EN ISO 13485:2016 Standard should be used as base for the establishment of the Quality Management System (KYS) for medical device producers.

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Installation of the appropriate
infrastructure and guidance

First of all, medical device producers should form the necessary infrastructure and work environment while using the necessities of the

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Process Validations

The validation of processes is one of the most slogged on issue among medical device producers. Medical device producers frequently confuse especially the validation, verification and revalidation concepts.

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2017/745/EU
Medical Device Technical Files

First of all, medical device producers should conduct the classification of the product that they have produced with the consideration of the usage area, purpose of use and the product

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Medical Device Risk Management

Medical device producers should prepare the Risk Management File for products that they have produced in compliance with the EN ISO 14971  Standard and based on

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Clinical Evaluation

In accordance with the Meddev 2.7.1 Rev 4 Guide, medical device producers should verify;
The clinical benefit
The clinical security
The clinical performance

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Post Market Surveillance (PMS)

Post Market Surveillance (PMS), is the ensemble of the processes and activities to monitor the performance of a medical device. These activities are designed to produce information

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Biological Evaluation

The medical device producer is responsible to prove that their medical devices would not cause any harm to the tissue in case it contacts with the tissue. Accordingly, biological assessment study should

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Usability Service

Medical device producers must complete the usability study in accordance with the structure of their medical device before releasing the product on the market.

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Software Validation

Producers that produce a medical device which consists of a software must finalize the software validation study in accordance with the EN

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ISO 13485 and CE Certification

Conformed Training and Consulting Services

CONFORMED Training and Consultancy Services Co. Ltd. provides training and consultancy services for ISO 13485 and CE Certification processes required for medical device manufacturers.

By prioritizing customer satisfaction, continuously enhancing the company image, and providing full-time and professional solutions, we aim to deliver the best service to our clients.

To enable our medical device manufacturers to produce products in compliance with national and international standards, regulations, legislation, and guidelines.

Call Us

+90 544 937 82 53

+90 544 937 82 53

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REFERENCES

USEFUL INFORMATION

What is the 2017/745/EEC Medical Device Regulation (MDR)?

20 October 2024|

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 [...]

WHAT IS MEDICAL DEVICE CE MARKING AND CE CERTIFICATION?

22 September 2022|

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 [...]

WHAT IS ISO 13485 CERTIFICATE?

22 September 2022|

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 [...]