Testimonials

Eoin McEvoy Quality Manager of IsoVasc Medical

“As a start-up medical device company, Isovasc Medical found Anne Marie from Limehill Quality Solutions to be an excellent partner to work with. We engaged Anne Marie to carry out an internal audit of our Quality Management System in preparation for our initial BSI ISO 13485 certification audits.

Anne Marie conducted a thorough and comprehensive audit, providing valuable insight into our readiness for the Stage 1 and Stage 2 certification audits. Her expertise in ISO 13485, the Medical Device Regulation (MDR), and medical device quality systems enabled her to identify deficiencies and areas for improvement within our QMS before the external audits. Addressing these issues in advance contributed to a smooth certification process.

She has an excellent understanding of ISO 13485 and MDR requirements and communicates audit findings and regulatory expectations in a clear and practical way. Her professionalism, attention to detail, and thoroughness were invaluable throughout the process.

Isovasc Medical would have no hesitation in recommending Anne Marie and Limehill Quality Solutions to any medical device company, particularly start-ups preparing for ISO 13485 certification or MDR compliance. We look forward to continuing to work with Anne Marie and Limehill Quality Solutions as a trusted partner for future audits and quality and regulatory projects. “

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.

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."

Seamus Kelly, Regulatory Manager at ATD emolda "I highly recommend Anne Marie for any validation roles you may require around medical device sterile barriers. I contacted Anne Marie to support our revalidations of SBS over 2 years at B Braun in Sligo.

Anne Marie possesses a deep knowledge and ability to execute the material section as required by ISO 11607-1 and the engineering validation needed for ISO 11607-2. She seamlessly adapted to our different sealing machinery platforms and delivered the IQ/OQ/PQ Executions with final report development to leave the company in a solid audit ready and compliant state for NSAI audits.

As a contractor, Anne Marie integrated effortlessly with our cross-functional teams and required zero hand-holding. She is a dedicated compliance expert who consistently challenged us and assisted us through meticulous work. She will be an immediate asset to any organization".

Andrea Lally, Senior R&D Chemist  "It was a pleasure to work with Anne Marie on packaging validations to ISO 11607. Her knowledge, professionalism and attention to detail were evident throughout all stages of the project ensuring a high standard of work and regulatory compliance".

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 on received on time and provide a true, accurate and detailed representation of the area audited. "

Gary Dillon Managing Director at Dillon Engineering Services
"I’ve worked with Anne Marie throughout 2021 through her company Limehill Quality Solutions and she has done a great job. Anne Marie was on assignment with a global medical device company based in the west of Ireland. She supported the medical device client in the area of packaging validation as part of their MDR remediation project. Her attention to detail and client interactions were highly appreciated by the client. I would highly recommend Ann Marie for any quality related assignment and look forward to working with her again in the future."

Paula Rice Co Founder and Partner at F4G Ltd
"Anne Marie displays an evident passion for her subject matter and approaches every task meticulously. She brings theory to life through practical examples and experiences and Anne Marie will work with her clients to ensure rigorous application of standards whilst educating and onboarding key personnel."

Ursula Brosnahan QC/QA Contractor at Ursula Brosnahan
"The course delivered by Anne Marie was very informative with plenty of discussions around the new standard and its implementation in Laboratories. I especially benefited from the discussions and examples given regarding Risk Assessment, Impartiality and Measurements of Uncertainty."

Jeoffry Collins Quality Manager at Kerry EMEA Region Newmarket
"The Uncertainty of Measurement training course went across very well. All concerned felt that it was set at just the right level for them as beginners approaching the subject for the first time. The worked examples were of great assistance in explaining the calculations involved. The pace of training allowed all concerned to grasp the concepts without overloading them with too much detail. Overall the feedback from all participants was really positive which was very encouraging given that it was done remotely. Also, it was felt that remote completion of the course was a very safe yet effective means of providing the training."

Mary Corcoran Regulatory Affairs Manager at Amcor Flexibles EMEA
"Anne Marie is professional, kind and inclusive in her approach to all. She is an excellent communicator, clear and concise and cuts to the chase. Anne Marie is an experienced and knowledgeable person with a strong work ethic and cares about her role and her co-workers. As a trainer she imparts her knowledge in a fair-minded and balanced manner."

Annette Conneely CQE Transformation and Training Analyst at HID Global
"Anne Marie is highly effective at resolving complex problems and her ability to bring colleagues on board results in a great team effort. Anne Marie is the professional to have on your team." 

Therese O'Shea QC Laboratory Manager at Carbery
"Anne-Maire is an excellent tutor and again another very good SQT course. We have a much better understanding of measurement of uncertainty now thanks to this course and would highly recommend this course to other laboratories." 

Jayne Mullally QC Central Laboratory Manager at Dairygold Co-operative Society Ltd 
"Anne-Marie was an excellent tutor throughout the course. Very competent in making complex theory and calculations applicable and usable by all on the course"