QualiMan-Assist is a consulting firm & assists South African registered companies, wishing to become medical device establishments, with compiling applications for submission to the regulator (SAHPRA); as well as assist with ISO13485 implementation.
Product or Service
10213 - Business and Management Consulting and Public Relations Services
Facility
OtherProduct Certification
Product or Service Certification |
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MEDICAL DEVICE SPECIALIST/ CONSULTANT
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Contact Infomation
Company Name: QualiMan-Assist
Company Address: 7 Victoria Walk, Woodstock, Cape Town, 7441, South Africa
Company General Phone: +27 79 342 2827
Company General Mail: info@qualiman-assist.co.za
Company Website: https://qualiman-assist.co.za
Key Contact: Fadzai Tsitsi Chakaingesu
Key Contact Phone: +27 78 099 7347
Key Contact General Mail: info@qualiman-assist.co.za
Company Information
Incorporation Date: September 09, 2020
BEE: BEE Level 1
Woman-Owned: Yes - 100% Woman Owned
Company Size: 1 – 5
Distribution: Other
Company Overview: QualiMan-Assist is a consulting firm & assists South African registered companies, wishing to become medical device establishments, with compiling applications for submission to the regulatory authority/Regulator (SAHPRA). We also assist with medical device regulatory queries, as well as compilation of medical device license amendment applications. Furthermore, we assist with the implementation of a medical device QMS according to ISO 13485:2016
Year Started Exporting: |
Not Yet Exporting |
Countries Currently Exporting to: |
None |
Countries Hoping to Export to: |
Australia, Canada, China, South Africa, United Kingdom, United States |
Registered Under the Following Trade Agreements: |
None |