Quality

Quality Compliance

P3 Medical operates a robust Quality Management System that is independently assessed and certified to internationally recognised standards. Our system is certified to ISO 9001:2015 and ISO 13485:2016, and complies with Directive 93/42/EEC and the Medical Devices Regulations 2002 (UK MDR 2002) for applicable products.

P3 Medical is audited by SGS, acting as both Notified Body 1639 and Approved Body 0120, providing independent assurance that our systems, processes, and products meet the highest regulatory and quality requirements.

Copies of our current certifications can be accessed via the SGS Certified Client Directory here.