We provide the following medical device market access regulatory consulting services  (Page.1)

U S market

I. FDA Device Registration and Listing

II. 510K(Device Advice Premarket Notification)

III. US FDA 21 CFR part 820 training

IV. U.S agent service

            E U market

I. EC declaration of conformity

II. Preparation of CE technical files

III. Preparation of Clinical report for madical devices

IV. Authorized European 

We provide the following medical device market access regulatory consulting

services  (Page.2)

A U market

I.ARTG registration for medical devices

II.Sponser service

III.A.U agent service

International standards

I. ISO9001:2015 Quality System Certification Consulting

II.ISO13485:2016 Medical Device Quality System Certification Consulting

III.Medical Device Single Audit Program (MDSAP) Certification Consulting

SPICA MEDTECH CERTIFICATION COMPANY  has employed dozens of long-term online medical equipment legal engineers, system external auditors, product standards experts and consulting counselors; it also has a high-level expert team overseas. Stable consultants: FDA decommissioned auditors in the US, RDC officials in Brazil, representative offices in Germany, and MDSAP auditors. In order to meet the needs of customers,SPICA U.K strives to provide the highest quality technical strength.

The website was produced by SPICA  U.K  in 2019. @