Application Review and Agreement Process Sample Clauses
Application Review and Agreement Process. 1.1.1. Applications for product conformity assessment regarding to the Regulation (EU) 2017/745 concerning Medical Devices shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company must fill in and sign the application forms completely. The documents required in the application form, the QMS documentation and the Technical Documentation must be delivered to SZUTEST Konformitätsbewertungsstelle GmbH along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form.
1.1.2. SZUTEST Konformitätsbewertungsstelle GmbH shall initiate the application review process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST Konformitätsbewertungsstelle GmbH may consult to the Federal Institute for Drugs and Medical Devices listed in the ▇▇▇▇▇://▇▇▇.▇▇▇▇▇.▇▇ web site based on their scope of coverage in Germany or competent authorities of other Member States during the process of application assessment. During the application the company shall inform SZUTEST Konformitätsbewertungsstelle GmbH for the missing parts of the Technical Documentation together with a plan and declaration for completeness. SZUTEST Konformitätsbewertungsstelle GmbH shall take this into consideration. If the application review identifies missing parts for the Technical Documentation, the company shall submit these documents not later than the imposed deadline by SZUTEST Konformitätsbewertungsstelle GmbH. If the required documentation will not be received within maximum 15 days after the imposed date, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the application.
1.1.3. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous Notified Body or Certification Body of the company or demand the company to provide the reports and documents issued by that notified body or certification body for transfer applications.
1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed.
1.1.5. In case the application assessment results positively, an agreement shall be signed with the company.
1.1.6. Upon the signature of the agreement, the company must pe...
Application Review and Agreement Process. 1.1.1. Applications for product conformity and ISO 13485 assessment concerning Medical Devices shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company shall fill in and sign the application forms completely. The documents required in the application form shall be delivered to SZUTEST along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form.
1.1.2. SZUTEST shall initiate the application assessment process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST may consult to the Competent Authority during the process of application assessment.
1.1.3. SZUTEST may contact the previous Notified Body or Certification Body of the company or demand the company to provide the reports and documents issued by that notified body or certification body for transfer applications.
1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed.
1.1.5. In case the application assessment results positively, an agreement shall be signed with the company.
1.1.6. Upon the signature of the agreement, the company shall perform the financial obligations provided in the agreement and deliver all the documentation including specifically the Technical File, Design dossier and quality management system documentation to SZUTEST within maximum 10 business days.
1.1.7. As for transfer applications, SZUTEST may demand the company and the previous notified body to execute a transfer agreement with no financial value.
1.1.8. SZUTEST may contact the previous notified body or certification body of the company for transfer applications and reject the application of the company according to the information given. If it is not possible to receive information from the previous notified body or certification body, SZUTEST may evaluate the application as a new application or else reject it.
1.1.9. After the agreement is executed, the documentation delivered by the company shall be reviewed and missing documents, if any, shall be determined and notified to the company. The company shall deliver the missing documents within maximum 10 business days....