CE Marking Support, for organisations bringing medical devices to the European market
Turning medical innovation into certified, market-ready products through structured regulatory strategy and notified body preparation.
No certification.
No Market.
Medical device manufacturers must navigate classification, technical documentation, quality systems and notified body assessment before a device can be placed on the market.
Each step introduces regulatory scrutiny, and misalignment between regulatory, clinical and quality strategy can delay certification.
For organisations bringing new devices to market, the pathway can quickly become complex without clear regulatory direction.
Structured regulatory guidance brings clarity to that process.
How we support organisations
Support designed to guide devices through certification and into the European market
Regulatory Strategy and Device Classification
We help determine the appropriate device classification and regulatory pathway under EU MDR or IVDR
Post-Market Surveillance Preparation
We support the development of PMS and vigilance systems required after devices are placed on the market.
Quality Management System Implementation
We help organisations establish and strengthen ISO 13485-compliant quality management systems.
Technical Documentation Development
We support the preparation and review of technical documentation required for conformity assessment.
Notified Body Preparation and Liaison
We support organisations in preparing for notified body engagement and managing the certification process.
Why choose The Other Consultants?
Independent auditing shaped by real certification experience.
UKAS-witnessed Lead Auditor
Independent and objective
Certification body and notified body perspective
Over 50 ISO 13485 and MDR audits conducted
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"Just to let you know that today’s audit on design didn’t raise any CARs...
they accepted that we had a strong internal audit conducted and that our QMS was working and flagging issues”
PRRC of a IIa medical device manufacturer.
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“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
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“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
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“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
“CE marking is more than a certification step. It’s the process that ensures medical devices entering the European market meet the standards patients and regulators expect.”
Adam Isaacs Rae, Founder
Preparing your device for CE marking?
If your organisation is planning certification or preparing for notified body review, we’re here to help.