Quality & Regulatory Audits

Improvement-based Quality System Audits

I have over 20 years of auditing experience and have performed internal quality audits, supplier audits, medical device tracking audits, design history file audits and unannounced audits across Europe and the US against the requirements of regulations and standards such as ISO 9001, ISO 17025, ISO 13485, MDSAP, FDA 21 CFR, EU MDR, UK MDR, IEC 62304, ISO 14971 & ISO 11607 Many standards and regulations have been updated over the last five years. I have conducted gap and preassessment audits for startup companies and SMEs transitioning to the new requirements.

I am sympathetic to the challenge of startup companies and provide thorough audits to prepare companies for stage 1 and stage 2 certification audits and beyond. I appreciate that it is often easier for external auditors to highlight and resolve concerns before visits by regulators and notified bodies.

SiMD & SaMD

Software as a medical device (SaMD) and Software in a medical device (SiMD) are the two main types of medical software reshaping the medical device sector and have the potential to benefit millions of people's lives. Medical device software manufacturers must define and document the design and development process, and notified bodies check these requirements.

I have supported startups designing and developing SiMD and SaMD through their ISO 13485:2016 stage 1 and stage 2 certification audits. One of the biggest challenges for start-ups is providing the documentation and records required to

satisfy the requirements of standards and regulations such as FDA 21 CFR section 820.30, ISO 13485 section 7.3, ISO 14971:2019 and IEC 62304:2006 + AMD1:2015.

 

Audit Preparation

My audits begin with a line-by-line review of your company procedures against applicable regulations and standards requirements. I consider the audit preparation phase equally crucial as the live audit.

Live Audit I understand what it's like to be an auditee, so my approach is professional but friendly. My questioning style encourages auditees to recognise non-conformances and identify opportunities for improvement. Clients often utilise my auditing service to have trainee auditors shadow an experienced auditor and reinforce employee understanding of the applicable regulation and standards. The combination of my 20+ years of industry experience and my role as a trainer allows me to provide examples of what works well. Where helpful, I explain my rationale behind my audit questions, including showing the auditee the specific section of the specification, standard or regulation.

 

Audit findings and audit reporting

The category of audit findings is discussed and agreed upon with the client fairly and objectively. Reports include a detailed audit trail and audit findings that reference the specific requirement.

I deliver a two day Internal Quality Auditing course through my training partner SQT Training Ltd.