Quality & Regulatory Audits

Identify compliance gaps before your notified body or regulatory body, reducing costly nonconformances and improving audit readiness.

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.

Peter McGuinness, CEO of Home Care Medical.  "Anne Marie was proactive, identified areas for improvement, engaged and developed our internal audit staff, and overall got great engagement with all team members. Anne Marie managed a big piece of work in preparation for our first HPRA audit. All Medical devices were identified and she ensured we followed all regulations. We managed this 2-day audit very well and came out of it with positive comments. She subsequently managed the follow up to this audit to completion. Our experience was that Anne Marie has a very good knowledge of Medical Device regulations. Anne Marie took responsibility for 2 external ISO audits which she managed successfully and with incident or fuss. She got on very well with external auditors.  She was most thorough and well informed in all her work and was most constructive in dealing with and educating and encouraging our staff. She worked to tight deadlines without fuss. She was always flexible and did not waste time. She was very practical in her work with us. While these are just some of our experiences, I have no hesitation in recommending Anne Marie in providing Consultancy services and you can feel free to contact me directly if you wish."

Caroline Kirwan Director of Regulatory Affairs and Quality at Cumulus NeuroScience Ltd. " Anne Marie has been an auditing partner with companies I’ve worked at over the last 6+ years. I have worked with her on a range a different audit types, including full ISO 13485 QMS audits, production specific audits, IEC 62304 software lifecycle audits, medical device design history file audits and supplier process audits. These have covered both high risk and low risk medical devices, from Class I device to Class III devices and covered a range of standards and QMS requirements including 21 CFR 820 requirements. Anne Marie’s professionalism and attention to detail is second to none. Also her understanding of requirements and the process of transferring these requirements into real world medical device Quality Management Systems is extensive. She draws upon her extensive experience in the industry and her years of consulting to provide a thorough audit while also providing welcomed insight on opportunities for improvements. Deliverables have always been received on time and provide a true, accurate and detailed representation of the area audited."

John Nethaway, Quality Manager at Vitalograph "In previous roles as Quality Manager in various companies, I worked closely with Anne Marie on various ISO 13485 and ISO 9001 projects. I found Anne Marie to be an excellent person to work with, she has tremendous attention to detail, is very knowledgeable and experienced in all aspects of ISO 13485 and ISO 9001. I thoroughly recommend her as an Auditor and Consultant."

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.