Supporting Medical Device Innovators

Quality & Regulatory Consultancy
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Supporting Innovators

Are you a disruptive medical device technology innovator searching for reliable quality or regulatory support?

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 a nutshell, 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.

What I Do

Quality Management Systems

ISO 13485 / 21 Part 820 Quality Management System (QMS) design, development and implementation including training and maintenance.

Supplier and Internal Auditing

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.

Strategy development and execution

Medical device regulatory and quality strategy development and execution.

Client Testimonials

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.