Services

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.

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.

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.

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.

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.

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.

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.