Medical Device Quality & Regulatory Management
Adam Isaacs Rae
Welcome to The Other Consultants!
I created The Other Consultants to help and enable medical device and in vitro diagnostic manufacturers to develop, implement and manage their Quality and Regulatory Management Systems.
My vision is to enable organisations to utilise their Quality Management Systems (QMS) as a tool for improvement.
The QMS should not be a constraint to operate within, it should instead act as a tool to standardise, drive consistency, reduce costs, and above all else produces a device that will meet its intended purpose to ensure patient safety.
Adam Isaacs Rae
Do the right thing when no one is looking
Do the right thing when no one is looking
Notable Projects
Implementation of Supplier Quality Risk Management Framework
Remediation of Critical Notibied 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
Testimonials
“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.”
Matthew 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