Regulatory & Technical Documentation

Technical – Structured – Pratical

Technical Documentation That Supports Your Product

New technical documentation.
Reviewing existing technical files.
Gap assessments.
Restructuring poorly organised files.
Closing missing-documentation gaps.
Preparing documents for regulatory review.
Product change and lifecycle documentation.

The steps we follow to
Support Your Compliance

Whether developing a new technical file or reviewing an established product, we follow our structured approach.

Understand Product & Requirements

Reviewing devices, intended purpose, classification, target markets and documentation. Allows us to understand the scope of the project.

Step – 2

Review, Plan & Identify Gaps

Existing documentation is assessed to identify missing or incomplete information. Allowing us to plan for improvments.

Step – 3

Develop, Review & Maintain

We work with your team to develop or remediate the required documentation, supporting implementation through to completion.

Development to Post-Market

Supporting the Complete Medical Device Product Lifecycle

New Regulatory Documentation

Support with the development and compilation of structured medical device technical documentation for new products, helping establish a clear and manageable technical file from the outset.

Technical File Review

Independent review of existing technical files to identify documentation gaps, inconsistencies and areas requiring improvement, followed by practical support to address the findings.

Product Lifecycle Support

Ongoing regulatory and quality support to maintain technical documentation with design changes, supplier changes, manufacturing updates or other developments.

Bernie brings a lot of knowledge on quality and regulatory matters. In addition she is a pleasure to work with, bringing enthusiasm and genuine interest. From my experience I would recommend her for supplier audits and internal audits.

Hannah R.

Microsoft AI Product Lead

The independent auditor on our internal audit programme to help us ensure we meet ISO13485 standards and I highly recommend her for such activities. I always learn something from Bernie’s audits and enjoy her positive and supportive approach to compliance;

Sarah M.

Lifescience & Health Business Consultant

It was a pleasure working with Bernie. She made managing quality management systems effortless and could be counted on to host regulatory audits successfully. She was very adept at devising practical solutions to problems.

Mauro C.

Quality & Regulatory Compliance Executive