I break down the complexity of the applicable medical device regulations and standards and deliver tailor-made solutions that work for you (considering your timescale, resources and available budget). In essence; I do the work, so you don’t have to. My aim is to reduce your workload, remove stress and to provide clarity and confidence concerning your organisation’s quality and regulatory obligations.
My services ensure that your organisation is consistently audit-ready and that the safety and performance of your medical device is assured.
ISO 13485 / 21 Part 820 Quality Management System (QMS) design, development and implementation including training and maintenance.
A customised-QMS for your specific organisational structure and business strategy will enable your company to operate in the highly regulated medical device industry sector. Neasa will develop a bespoke QMS that will allow you to comply with industry requirements, regulations and standards. Engagement and collaboration with your quality team during development ensures that the implemented QMS is appropriate, user friendly and can be maintained by you without the need for further consultancy support.
Supplier and Internal Auditing including report generation and audit follow-up activities, e.g., non-conformance issuance, support with corrective and preventative actions, and follow-up auditing.
As a certified lead auditor, Neasa regularly conducts on-site supplier audits to support the client’s supplier management system. Audit execution includes liaising with the supplier to confirm appropriate dates, reaching consensus on the audit agenda, completing the audit at the supplier’s facility as per the appropriate medical device regulations and finalising the audit report including findings.
Neasa also acts as the lead internal auditor for a number of clients. She collaborates to finalise the annual internal audit schedule, completes on-site quality system audits at the client’s facility and issues the internal audit report.
Medical device regulatory and quality strategy development and execution.
Neasa works with technology innovators and Start-Ups to develop appropriate regulatory and quality strategies that align with the regulatory requirements and industry standards. A finely-honed strategy has the potential to facilitate success with grant-applications, market expansion, investor meetings and discussions with Notified Bodies and Competent Authorities. Clients have engaged Neasa to consult on early stage medical device development projects, EU grant applications, expansion into global markets, and during scientific meetings with Notified Bodies and Competent Authorities.
Quality Management System (QMS) continuous improvement related to annual quality objectives, Key Performance Indicators (KPIs) and alignment with upgraded regulatory requirements and standards.
Supporting clients to upgrade their existing QMS to adhere to global regulations in times of commercial distribution growth is a frequently requested service that Neasa provides. She also updates her client’s QMS in line with standard updates, e.g., ISO 13485 update in March 2016, and continues to work with existing clients on transition plans and QMS enhancement related to regulatory changes, e.g., EU MDR.
Training development and delivery related to medical device requirements and standards together with industry trends and practical know how.
Neasa has delivered numerous custom-made training sessions for clients wishing to increase their knowledge and understanding of the industry. Training on the CE mark process, risk management in the medical device industry including the ISO 14971:2012 updates, EU MDR update analysis, industry trends and general medical device training for non-quality staff have been successfully delivered and have received positive client feedback.
Post Market Surveillance (PMS) process analysis and improvement.
Catering for a diverse client base that includes many virtual manufacturers who sub-contract activities such as medical device design, manufacture and distribution is one of Neasa’s specialities. In order for such manufacturers to comply with their regulatory obligations, a strong Post Market Surveillance (PMS) process is essential.
Neasa audits the complaint handling, vigilance and medical device reporting systems, including performing an analysis of the post market clinical follow-up planning and field action / recall processes to determine the updates necessary to ensure ongoing compliance to regulatory requirements. She works with clients to implement the improvements required and ensures the client remains audit-ready for both Notified Bodies and Competent Authorities.
CE Mark submission, 510(k) and PMA application and clinical investigation (also known as clinical trial) planning and execution support.
Neasa collaborates with clients on their medical device regulatory submissions and applications to regulatory authorities. She has attended scientific meetings and discussions with Notified Bodies to align with the regulator’s expectations and timelines. Neasa continues to work with clients on their Clinical Evaluation Summary (CES) analysis to determine whether additional clinical data is required for the related regulatory filing. Neasa has supported clients to execute clinical investigations (also known as clinical trials) as part of pre-market and on-market clinical data gathering, guaranteeing that sufficient data is available to confirm the safety and performance of the client’s medical device.
"I find her to be exceptionally knowledgeable about the regulations and quality system requirements whilst also maintaining the flexibility to find practical solutions that work for country and region- …"Read Full Testimonial
"I highly recommend her as a quality system and medical device Subject Matter Expert. She is a reliable consultant that will guide any organisation towards success in the medical device industry."Read Full Testimonial
"Neasa worked alongside the Cosmo quality team to upgrade the QMS to ensure audit-readiness. Her support was invaluable in achieving a successful MDSAP audit outcome."Read Full Testimonial
"I consider Neasa to be an expert in her field who works well with cross-functional teams and suppliers. She ensures that all her activities are completed to the highest standard and has the skill to b …"Read Full Testimonial
"I consider her to be an expert in medical device standards and requirements who is able to find company-specific solutions to ensure compliance."Read Full Testimonial
How Can I Help Your Project?
If you are a medical device innovator who demands excellence, then contact Neasa Greene Consulting today for an initial consultation.