Hello, I’m Adam and I’m a medical device quality and regulatory consultant.

I provide medical device consulting services to companies on quality and regulatory matters.

I take pride in becoming trusted partner delivering pragmatic and risk-based advice to enable organisations place safe and effective devices on the market, while considering their business goals. Regulatory consultancies must be mindful of the cost of compliance we create for manufacturers, and that remains one of my core values.

I’ve worked in the industry for 10 years - how time flies when you're having fun…

I work as a medical device consultant, but I'm also a qualified lead auditor who works with certification bodies. This gives me a unique view to understand the perspective of both sides of the table - the auditor and the auditee.

I strive to create genuine, human connections within the medical device manufacturing community.

As a regulatory consultant for medical devices, it is my role to put medical device organisations in safe hands when dealing with quality and regulatory matters relating to their device.

Notable Projects

Implementation of Supplier Quality Risk Management Framework

Remediation of Critical Notified Body Findings

Remediation of FDA Stop Sale

ISO 13485 and Medical Device Regulation Setup

Regulatory Submissions

Lean Six Sigma Critical Supplier Improvement

CAPA System Remediation and Improvement

Internal Audit Team Development and Training

More

Quality management consultancy

“Adam is a breath of fresh air when it comes to QARA, he takes the time to understand the needs of a client and communicate effectively. He is not afraid of a challenge and always goes above and beyond to not only ensure optimal results but that the end client "gets it". I highly recommend his services.”

Karandeep Singh Badwal, The Medical Device Podcast
“Adam is a highly knowledgeable Medtech professional who has a passion for the industry and its requirements. Adam hit the ground running supporting my requirements and is always dedicated. Adam brought his background and knowledge as part of a project in Supplier Quality working with critical partners including Six Sigma DMAIC and root cause analysis.”

QuMatthew Clark, European Supplier Quality Manager - CooperVision
“I have worked with Adam on several projects relating to Medical Devices, his regulatory experience and knowledge are exceptional and always up-to-date in the current climate of regulatory changes.”

Martin Coles, Operations Director - International Associates