About Trustfall Consulting

Guiding businesses through ISO standards with clarity and care.

Trustfall Consulting are highly experienced medical device certification specialists with over 20 years of industry expertise, we support organisations to achieve and maintain compliance across a wide range of international standards and regulatory frameworks. Our core competencies include ISO 9001, ISO 13485, ISO 27001 and ISO 45001 which enables us to provide targeted and integrated certification support tailored to your own business needs no matter how complex a business environment you have.

We specialise in both UK and European regulatory pathways, including the UK Conformity Assessed (UKCA) marking under the UK Medical Devices Regulations and compliance with the EU Medical Device Regulation. Our team has extensive experience guiding clients through the full certification lifecycle, from initial gap analysis and application preparation to audit readiness and post-certification maintenance.

Having worked closely with leading regulatory and accreditation bodies such as United Kingdom Accreditation Service and Medicines and Healthcare products Regulatory Agency, we understand the expectations and practical requirements needed to achieve successful outcomes. We also support organisations participating in the Medical Device Single Audit Program, ensuring alignment with global regulatory requirements and facilitating market access across multiple jurisdictions.

Our background spans senior leadership roles within certification bodies, approved bodies, and notified bodies, giving us a unique perspective on both the regulatory landscape and the audit process. This insight allows us to deliver pragmatic, efficient, and commercially focused solutions that reduce risk and streamline compliance.

We are totally committed to helping our clients navigate the increasingly complex regulatory environments with confidence, providing clear guidance, robust processes, and hands-on support at every stage of their certification journey.

We have more than 20 years experience in this industry.