MEDICAL DEVICE SPECIALIST/ CONSULTANT

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Fadzai Tsitsi Chakaingesu

+27 79 342 2827

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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

Other

Product Certification

Product or Service Certification

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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: [email protected]

Company Website: https://qualiman-assist.co.za

Key Contact: Fadzai Tsitsi Chakaingesu

Key Contact Phone: +27 78 099 7347

Key Contact General Mail: [email protected]

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