Blended Business Solutions
Management in Pretoria

Expert ISO 13485 and ISO 9001 consultancy. Specialises in Quality Management System development, implementation and internal auditing.
We help companies achieve or maintain certification by developing or improving their quality management systems.

Our skilled consultants can help you seamlessly integrate quality principles into your operations, surpassing customer expectations in the process.
We strive to be more than just a service provider; we aim to become your trusted business partner committed to ensuring long-term success through increased customer satisfaction, reduced operational costs, improved stakeholder relations, and better risk management.

Blended Business Solutions was established in September 2021 initially as a versatile business consulting firm offering services such as business plan and proposal writing, along with training support, including aiding companies in pursuit of accreditation with Services SETA. However, in 2023, a pivotal realization emerged regarding the necessity for ISO 13485 accreditation services. This realization stemmed from the mandatory requirement set forth by the South African Health Products Regulatory Authority (SAHPRA) mandating ISO 13485 certification as a prerequisite for license renewal and new license applications. The surge of medical devices companies, prompted by the onset of the COVID-19 pandemic, necessitated this adaptation. Amidst the proliferation of these medical devices firms, predominantly small-scale enterprises lacking ample financial resources for implementing Quality Management Systems (QMS), Blended Business Solutions recognized an opportunity to address this challenge.

While the prevailing scenario in the South African and African medical devices sector is characterized by substantial importation—accounting for 70-90% of medical devices—acknowledging the continent's progress and potential remains paramount. This recognition underscores the prospect for Blended Business Solutions to contribute meaningfully to this evolving landscape, offering accessible ISO 13485 QMS services tailored to small enterprises, and positioning itself as a catalyst within the sector's dynamic trajectory.