Question Title

* 1. INTRODUCTION
You are formally invited to voluntarily participate in a research study conducted by Sheina Rajkumar, Doctor of Philosophy (PhD) Candidate in Health Innovation at the University of Cape Town (UCT). I am currently conducting a research study entitled “Enhancing the South African Medical Device Landscape through the Advancement of Regulatory Procedures and Guidance Documentation”. The purpose of this study is to identify key roadblocks and recurrent issues associated with the development of a quality management system within medical device establishments in South Africa as well as the issues associated with successfully obtaining ISO 13485 certification. This study is solely for academic purposes. Collected data will be anonymised and analysed thematically, contributing to a better understanding of industry-wide challenges. Participation in the survey is entirely voluntary and no personally identifiable information is required to complete the survey. Participants are not required to disclose their names or any sensitive or confidential company information. On request, a summary of the outcomes of the study will be made known to you.

ELIGIBILITY CRITERIA:
1. At least 18 years of age.
2. Must possess fluency in the English language.
3. Minimum of a tertiary level of education.
4. At least 1 year of professional experience within the South African medical device industry.
5. Professional experience with developing and/or maintaining a QMS within a medical device related establishment.
6. Currently employed within a medical device related establishment commercialising in South Africa.

This includes the following types of establishments and its relation to the lifecycle of medical devices per ISO 13485:2016; an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).

PROCEDURE:
The study requires you to complete a survey questionnaire via SurveyMonkey about your experiences and the challenges encountered during the implementation process of a quality management system within a medical devices establishment, as well the procedure for obtaining ISO 9001/13485 certification within South Africa. The entire questionnaire will require approximately 15 minutes of your time.

CONFIDENTIALITY:
All information provided will be kept confidential and utilized solely for research purposes. No individual names will be recorded or published. You will not be requested to supply any identifiable information, ensuring anonymity of your responses.

PARTICIPATION:
Participation in this study is entirely voluntary. You may choose not to take part at all. If you decide to participate in this survey, you have the right to withdraw from the study at any time and for any reason, in adherence to ethical research guidelines.

ETHICAL CONSIDERATIONS:
There are no known risks associated with participating in this research study. This research will not expose you to any harm due to your participation. No personal information will be recorded, and your response is completely anonymous. By accepting to voluntarily participate and submitting a survey response, you are agreeing to the processing of your information in accordance with the Protection of Personal Information Act (POPIA). The information you provide within this survey will be used solely for the purposes of this research and will be treated as confidential. As this study involves the use of human research participants and is under the supervision of UCT, the study has received ethical approval from the University of Cape Town Human Research Ethics Committee.

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