servıces
2017/745 EU MDR Certification
The Medical Device Regulation (MDR), known as Regulation 2017/745
Known as Regulation 2017/745, is a regulation governing the marketing and use of medical devices in the European Union. MDR regulates the acquisition of CE certification for medical device manufacturers and imposes strict requirements regarding the safety and effectiveness of products.
Contact and Application
Our company provides CE certification services under the scope of MDR. For application and further information, please use the following contact details:
Email: application@notice.com.tr
Phone: +90 216 208 58 44
To access the application form and application instructions, you can visit the “Documents” section on our website.
Don’t hesitate to get in touch with us to express your questions, submit your applications, or convey your needs. We are here to assist you with all the requirements related to MDR compliance
Test Subcontractors
- Centre Testing lnternational Group Co., Ltd.
- Chemtox Biolab Arge Hiz. Ve Tic. Ltd. Şti
- Çınar Validasyon ve Denet Laboratuvarları Ltd. Şti.
- ERA Yönetim Test ve Belgelendirme Hiz. A.Ş
- Jiangsu Kerbio Medical Technology Group Co., Ltd.
- Labiotek Biyoteknoloji Laboratuvarlari Protez San. ve Tic. Ltd. Şti.
- Oxigen Analiz Laboratuvar Hiz. Tic. Ltd. Şti
ISO 13485:2016 QMS Certification
ISO 13485 standard is a customized quality management system for medical device manufacturers. It is a management standard to be implemented by manufacturers, organizations providing subcontracting, distribution and technical services related to medical devices.The main goal of the standard is harmonization of the legal requirements of medical devices.
ISO 13485 contains special requirements;
- Implementation of the quality management system
- Application of risk management approach to product development and production realization processes
- Validation of processes (Sterilization, software, production etc.)
- Effective recall and product traceability
- Installation activities
- Service activities
- Workplace control (physical and microbiological qualification)
BENEFITS
- Compliance with legal requirements – competent technical documentation
- Development and improvement of risk management approach according to ISO 14971 requirements
- Improvement of design and development process – validation reports, product tests, clinical evaluation, design dossier etc.
- Customer satisfaction
- Development of critical supplier control
CERTIFICATION PROCESSES
- Application
- Determination of the scope of the audit and collection of information on the producer
- Audit
- There is a two-stage audit in the initial certification process.
Stage 1
I. Verification of the quality management system
Ii. Documentation verification
Iii. Verificaiton of production area
Iv. Verification of certificaiton scope
V. Issuing audit report including improvement opportunities and nonconformities
Vi. Determination of Stage 2 audit date
Stage 2
I. Reviewing of objective evidence
Ii. In-depth control of records and documentation
Iii. Publishing a report including improvement opportunities and nonconformities
– Certificaiton
I. Issuing certificate upon committee decision
Ii. Determination of annual surveillance audits and re-certification processes.
93/42 EEC MDD Transition Period Services
CE Marking of Medical Devices According to 93/42/EEC Medical Devices Directive
NOTICE is appointed by the European Commission as Notified Body no 2764 for medical devices under the quality modules of the Medical Devices Directive, annexes II &V and has the expertise and experience to provide CE marking services.