Medical Device Regulation Service

Medical Device Regulation Service

Serivce Scope

 

USA FDA

The United States is the world’s largest single medical device market. At present, medical devices are managed by the US Food and Drug Association (USFDA). Voler Biotech Consulting Co., Ltd. has many years of FDA registration experience, and can assist client’s products in the listing, 510K and PMA registration of the FDA.
In addition to product registration services, we also have advanced consulting services to assist innovative products with FDA’s Q submission questions, which can improve the efficiency and risk of errors in the verification of innovative products.
In addition, we have experienced high-level consulting services in the establishment and inspection of FDA QSR 820 quality system. Let’s our client can successfully respond to FDA inspection audit.
1、FDA 510(k) submission(Medical Device & IVD)
2、PMA submision
3、De Novo submission
4、FDA Pre-submission Service
5、Product FDA Listing
6、Enterprise registeration in FDA

 

European

Medical devices register in the European Union need to obtain a CE mark before they can log into the European Union and establish a quality management system in accordance with the latest version of ISO13485. Voler Biotech Consulting Co., Ltd. provides complete services at all stages for CE certification of medical device, including ISO 13485 quality system certification planning and training. Assist customers to establish and meet the system certification requirements of various notify body; and provide guidance and assistance in the establishment of various technical requirements in the technical device files of products that comply with the MDD Directive (Medical Device Directive)
From 2020, the EU medical device management regulations will be completely changed to MDR regulations (Medical Device Regulation) to manage the medical device registration, certification, sales and post-market survellience within the EU. We can assist medical device manufacturers to obtain CE certification and ISO13485 compliance. Our services include the following:
1、EU Medical device CE mark consulting service
2、CE mark product techinical document follow ESPR(MDR) consulting
3、Qulaity system ISO 13485 consulting
4、Clinical Evaluation Report /Post market clinical follow(PMCF) and Post market Surveliience(PMS)
5、Euro Authorized Represntive(Euro ARep)registeration
6、SZUTEST Notified body CE certification(CE Mark 2195)
7、Compliance the latest MDR CE Mark regulation training

 

Taiwan,China,South Korea,India

Voler Biotech Consulting CO., Ltd. provides multi-national product registration services. Integrate international resources and rich experience to assist medical device manufacturers to register products in various countries.
1、Taiwan FDA class I/II/III product register
2、China NMPA medical device register include clinical trail study
3、Multi national product registeration