Innovative ISO 13485 Solutions For The Medical Device Sector 

South African Health Products Regulatory Authority (SAHPRA) have confirmed that ISO 13485 certification is a prerequisite for the issue or renewal of medical device manufacturer and distributor licences – with effect from 1 April 2025. 

This new regulatory requirement effectively implies that those medical device companies who have not achieved certification will in future not be considered for the issue of medical device licences – which is obvious cause for great concern. In an effort to address industry concerns and apprehension, JCA have identified the need to build capacity and improve the efficiency of the certification process. In this regard the JCA team are offering an effective and client-focused ISO 13485 certification solution as well as a comprehensive on-line, on-demand training programme that includes a full spectrum of modules tailored for the industry. 

The JCA ISO 13485 certification solution is receiving wide-spread acknowledgement as a practical and value adding process that provides assurance and promotes sustainability. At the core of the JCA certification solution is the critical drive to validate that a business’ quality management system (QMS) makes provision for the desired safety and efficacy of medical devices – ultimately to enable the health care sector to deliver the highest levels of patient care. 

The JCA team use hybrid audit techniques incorporating remote review, audio-visual, virtual and physical assessment in conformance with the ISO 17021 standard and relevant IAF MD guidelines. 

The unique audit techniques and use of technology not only improves the efficiency of the audit process, but also allows the client to have added personal engagement. In addition, the JCA solution offers significant cost benefit, which has been well received by the sector, especially in light of the current difficult economic landscape. 

Furthermore, in an industry first, the JCA team have launched a fully online and on-demand e-learning training program for ISO 13485 medical device certification. This innovation comes in response to the increasing demand for capacity building in the medical device sector, particularly in light of the SAHPRA directive. 

The JCA e-learning training program is designed to provide the sector with the knowledge and skills for the different role players involved in the medical device QMS processes. 

The training programme includes 3 courses: 

ISO 13485 Requirements : An introduction to the standard and the requirements of each clause. 

ISO 13485 Implementation : A detailed unpacking of how to implement the requirements in a medical device manufacturing or distribution business. 

ISO 13485 Internal Auditor Course : The internal audit function is an essential requirement of ISO 13485 certification. This course will equip internal auditors with the skills needed to conduct the internal audit against the requirement of the standard. 

JCA are offering all members of SAMED, MDMSA and SALDA a 30% discount on the training fees. 

JC Auditors are at the forefront of the ISO certification industry having conducted more than 10,000 audits over the last 15 years. The JCA team’s unwavering passion for innovation, efficiency and client-focused solutions has played a pivotal role in promoting safety, compliance, and continual improvement, benefitting businesses across the Southern African region. 

The JCA team would gladly set up a meeting to discuss specific questions related to one’s unique operations. 

The team may be contacted on info@jcauditors.com, Tel : 087 5500 212, Whatsapp : 082 858 9995, Mobile : 082 577 8494, web : www.jcauditors.com.

www.jcauditors.com/medical.