Reduced Regulatory Risk
We help you avoid delays, rejected submissions, and unnecessary compliance failures by ensuring your documentation and systems are structured correctly from the start.
- 082 570 6796
- info@consultico.co.za
Regulatory and Quality Support for Medical Devices and Healthcare Technologies
Medical device and healthcare technology regulations are complex and constantly evolving.
Incorrect or incomplete documentation can delay approvals or prevent access to the market entirely.
We help ensure your regulatory and quality systems are correctly structured from the start, reducing unnecessary risk.
Consultico supports medical device companies, IVD manufacturers, software and AI as a Medical Device developers, pharmaceutical distributors, and complementary health product businesses with structured regulatory and quality solutions. We help companies align with SAHPRA requirements, implement ISO 13485-compliant Quality Management Systems, and prepare complete technical documentation for market access in South Africa and beyond.
Entering or operating within the South African healthcare market requires compliance with SAHPRA regulations under Act 101 and Act 36. We assist with regulatory pathway identification, license applications, technical file compilation, Quality Management System implementation, gap analysis, SOP development, and long-term regulatory strategy planning. Our approach ensures your systems are practical, structured, and aligned with both local and international standards.
Whether you manufacture, import, distribute, or develop medical devices, IVDs, homecare technologies, wearable devices, AI-driven medical software, or pharmaceutical products, we provide structured compliance support tailored to your operational model. From consultation sessions to full regulatory system implementation, we help you reduce risk, accelerate approvals, and maintain long-term compliance without disrupting your core business operations.
Finding a consultant who can advise across all classes of medical devices can be challenging. We support companies in understanding which regulations apply, which licenses are required, and how to structure documentation correctly.
Whether you need full implementation or guidance to manage processes internally, we adapt to your preferred working model.
Read doctor-produced health and medical information written for you to make informed decisions about your health concerns.
We determine which regulations and standards apply, assist with licensing through SAHPRA, draft and compile technical files, and create strategic regulatory management plans.
We implement Quality Management Systems aligned with ISO 13485 and SAHPRA requirements, conduct gap analyses, develop SOPs, and train work groups to maintain compliance.
We provide consultation sessions, support market access preparation, and assist with resolving regulatory or quality risks that may affect operational continuity.
We usually begin by addressing your immediate concerns. From there, we build a structured long-term approach that aligns with regulatory and quality requirements.
Some companies prefer full outsourcing. Others prefer internal implementation with guidance. We support both.
We help you navigate Act 101, Act 36, SAHPRA regulations, and ISO 13485 frameworks while working according to your structure, budget, and preferred level of involvement.
We assist clients operating in:
We help you avoid delays, rejected submissions, and unnecessary compliance failures by ensuring your documentation and systems are structured correctly from the start.
We guide you through the correct regulatory pathway, helping you understand which licenses, standards, and frameworks apply to your product and market.
Your Quality Management System is built around your real operations — not theory — making it easier to maintain and adapt as your company grows.
We support you beyond initial implementation, helping you keep your regulatory and quality systems up to date as products evolve and requirements change.
Whether you want us to complete the work for you or train your team to manage it internally, we adapt our involvement to match your company's needs and resources.
Clarity Before Compliance Becomes a Problem. Book your first hour free consultation and understand exactly where you stand.