---
title: "Technical Documentation — Regulatory Affairs | QbD Group"
description: "The new regulations for IVDs and medical devices introduce more stringent requirements for technical documentation and clinical evidence. With over two dec"
url: https://qbdgroup.com/en/services/regulatory-affairs/technical-documentation
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Technical Documentation — Regulatory Affairs | QbD Group\", https://qbdgroup.com/en/services/regulatory-affairs/technical-documentation"
---

# Technical Documentation

Comprehensive regulatory documentation for MD & IVD

The new regulations for IVDs and medical devices introduce more stringent requirements for technical documentation and clinical evidence. With over two decades of experience, we offer unparalleled expertise.

## What is technical documentation?

The **new regulations** for IVDs and medical devices introduce more stringent requirements for technical documentation and clinical evidence. With **over two decades of experience**, we offer unparalleled expertise.

We handle your medical writing tasks and provide answers to your regulatory questions with precision and professionalism. Our experts stay on top of the evolving regulatory landscape so you can focus on what you do best.

## Why partner with QbD Group?

Tailor made solutions — We provide bespoke technical documentation services that align with your specific product requirements and regulatory pathway.

### Technical file compilation

Complete compilation or review of your technical documentation for MDR/IVDR compliance.

### Clinical evaluation

Clinical evaluation reports, literature reviews, and equivalence assessments.

### Risk management

Comprehensive risk management documentation aligned with ISO 14971.

### Gap assessment

Thorough gap assessments to identify and address documentation deficiencies.

Why QbD Group

## Your trusted partner

When it comes to regulatory requirements for your IVDs and medical devices, our team puts your needs first.

Over 20 years of experience in medical device and IVD technical documentation.

Expertise across all device classifications and regulatory pathways.

Deep understanding of MDR, IVDR, and international regulatory requirements.

Proven track record of successful Notified Body submissions.

## Let's talk Regulatory Affairs

From regulatory strategy to product approval, our experts are ready to guide you through every step.

Contact us

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Source: https://qbdgroup.com/en/services/regulatory-affairs/technical-documentation — © QbD Group. Quote freely with attribution and a link back.