About Us
- 25+ years of experience
- Former Quality Engineer and Quality & Regulatory Manager
- Start up experience
- Lead auditor for 20+ years
- Member of NSAI national standards healthcare committee
- Medical Device Specialist
- Estimation of Measurement Uncertainty Specialist
Medical Device Consulting and Auditing
We provide end-to-end support for medical device manufacturers and suppliers to this sector, including:
- Regulatory compliance strategy and implementation.
- ISO 13485 Quality Management System development, including pre-certification stage 1 and stage 2 audits, routine internal quality auditing & unannounced audits. Clients often utilise the auditing service to have trainee auditors shadow an experienced auditor and to reinforce employee understanding of the applicable regulation and standards.
- Hosting audits with Notified Bodies and Competent Authorities, including pre and follow up supports.
- EU MDR support for Importers and Distributors, articles 13 and 14.
- Risk management aligned with ISO 14971
- Post-market surveillance and vigilance support
- Supplier quality management and qualification
- Short-term quality and regulatory contractor support
Laboratory Consulting and Auditing
We assist laboratories in meeting quality and accreditation standards through:
- ISO/IEC 17025 implementation and compliance support
- Quality system development and improvement
- Laboratory documentation, SOP creation, and validation guidance
- Internal audit preparation and gap assessments
- Accreditation readiness support
- Estimation of Measurement Uncertainty for testing laboratories performing physical, chemical and microbiological testing.
- Support with Proficiency Test Results and Corrective Actions
Training Services
We deliver structured and customised training programs designed to build competency, improve compliance, and strengthen teams. All training is delivered through our training partner SQT Training Ltd.
All training sessions can be delivered on-site, online, or in hybrid formats, depending on your needs.
Our participation in the NSAI TC005 Healthcare Standards Committee provides early insight into upcoming changes to standards and enables collaboration with peers to shape international best practices.
Limehill Quality Solutions was established in 2020 by Anne Marie Newell. Limehill Quality Solutions focuses specifically on the medical device and laboratory sectors.
The company is based in Galway, Ireland, and provides support in Ireland, the UK, and beyond, covering compliance with ISO standards and Regulations. Every organisation is different, and our support spans start-ups, SMEs, multinationals, and service providers. Our services are tailored to your size, product and service type, and compliance goals.
Lastly, Limehill is the name of the townland where Anne Marie Newell was born in County Tyrone, and now lives in County Galway. She has over twenty-five years of experience as a quality professional, including 7 years working as a Quality Manager and 12 years as a Consultant and holds a Black Belt in Six Sigma and is an established Lead Auditor.
Contact us today to discuss your compliance, training, or auditing needs.