Clarity
State the position plainly, including what is known, what is not and what requires attention.
About Clearline
Experienced regulatory and quality support, led by Caroline Timberlake.
Clearline was created to help medical device businesses make sense of regulatory and quality situations that have become unclear, fragmented or difficult to sustain.
Caroline Timberlake · Founder and Principal Consultant
The person shaping the work is the person doing it.
Caroline Timberlake is the founder and Principal Consultant at Clearline Regulatory. She has extensive experience in medical device Quality Assurance and Regulatory Affairs, gained through senior positions in both manufacturing and consultancy.
Caroline helps clients navigate complex regulatory and quality challenges in a clear and practical way. Her areas of expertise include regulatory strategy, ISO 13485 quality management systems, internal audits and audit readiness, technical documentation, EU MDR and UKCA transition, and fractional QA/RA support.
Her career has included leading regulatory and quality teams, managing complex remediation programmes, responding to regulators and Notified Bodies, and supporting manufacturers through significant regulatory change. She understands that compliance must not only withstand scrutiny, but also work effectively within the day-to-day realities of a business.
Caroline established Clearline Regulatory to provide straightforward, experienced and dependable support to medical device businesses.
What Clearline stands for
Good regulatory and quality support should make the situation clearer.
Proportion
Direct effort towards the controls and evidence that genuinely matter in the client’s context.
Practicality
Create work that people can operate, own and sustain after the engagement ends.
Integrity
Be honest about fit, scope, uncertainty and when a different specialist is needed.
Why Clearline
From a crowded picture to a reliable line forward.
The Clearline name expresses the role the consultancy is designed to play: bringing the current position into view and creating a practical route through the work ahead.
That does not mean making complex requirements simplistic. It means giving clients enough structure to understand the complexity, make sound decisions and move forward with control.
A practical first conversation
Start with the situation as it is.
Tell us what is happening, what has changed and where you need clarity. We will consider whether Clearline is the right fit and suggest a sensible next step.
Discuss your requirements