What happens if you don’t develop within in ISO 13485 framework?
Failing to work with an ISO 13485-accredited design partner can expose your medical device development to serious risks. Regulatory rejection is a major concern, as your device may not meet the minimum standards for approval, leading to costly redesigns or even outright denial.
Without proper documentation and risk controls, safety issues may arise, potentially triggering product recalls that damage both your brand and financial standing. Legal liability is another critical risk; if a non-compliant device harms a patient, your company could face lawsuits and regulatory penalties. Additionally, the absence of ISO 13485 compliance can erode trust amongst healthcare providers, investors and strategic partners, undermining your credibility and commercial viability. Operational inefficiencies also become more likely, as teams may struggle with inconsistent processes, poor communication and avoidable errors due to the lack of a structured quality management system.