Build

Build with IVDeology

IVDeology partners with you to build your Regulatory Strategy, Quality Management System and Technical Documentation, ensuring you meet your key objectives and project timelines whilst also establishing your company-wide Quality Culture.

Build your Regulatory & Quality Systems

Regulatory
Strategy

IVDeology provides tailored solutions for developing and implementing effective regulatory strategies, offering expertise in risk assessment, compliance frameworks and regulatory technology integration.

Quality Management
System

Develop a compliant and effective QMS tailored to your specific IVD products. Our structured approach ensures your system meets global regulatory requirements while enabling operational excellence.

Technical
Documentation

Whether you’re starting from scratch, reviewing existing documentation, or need templates, we can ensure that your technical files are comprehensive, compliant with regulations and ready for submission.

Quality
Culture

Embed quality principles throughout your organisation with our comprehensive approach to quality culture. We help you establish behaviors, attitudes, and processes that prioritise quality at every level.

Regulatory Strategy

Your Regulatory Strategy is the starting point from which we will create a structured framework to work within. It is a critical step in allowing you to decide which markets to enter, by providing an evaluation of regulatory environments and entry requirements including class definitions, timelines and pre-market approval processes. Planning your Regulatory Strategy includes:

  • Setting out clear objectives and scope that define what the regulations aim to achieve and which entities or activities are subject to them
  • Legal and institutional frameworks that establish the authority for regulation and the agencies responsible for implementation
  • Regulatory standards or requirements that specify acceptable practices, limits, or thresholds
  • Reporting and transparency requirements for regulated entities
  • Risk assessment methodologies to identify and prioritise regulatory concerns
  • Cost-benefit analysis requirements to evaluate regulatory impacts

Quality Management System

IVDeology can help you develop a Quality Management System that is both compliant and effective, either from the ground up, or by doing a gap analysis of your existing processes and building onto this. Our QMS support services can help you work towards expansion to cover international standards, as we work together through the below checkpoints:

  • Defining QMS processes and procedures
  • Document control and record keeping
  • Risk management
  • Employee training and competency
  • Monitoring, measuring and auditing
  • Non-conformance and corrective actions
  • Continuous improvement and maintenance
  • Post-market surveillance
  • Scientific Validity and Performance Evaluation

Technical Documentation

Supporting you throughout the process of creating and maintaining technical file documentation, IVDeology’s expert team guides you through the process of developing compliant and effective technical files that satisfy UK, EU, US and other regulatory requirements, including:

  • Gap analysis of existing technical documentation against IVD requirements
  • Development of documentation strategies tailored to your product portfolio
  • Creation of templates and standardised formats for consistent documentation
  • Support for performance evaluation and scientific validity documentation
  • Risk management documentation aligned with ISO 14971
  • Post-market surveillance and vigilance documentation systems
  • Expert review and verification of completed documentation packages

Quality Culture

At IVDeology, we help you build an organisational culture where quality is integrated into every aspect of your operations. We work collaboratively with your team to develop a Quality Culture that includes:

  • An overarching assessment to identify strengths and opportunities
  • Leadership engagement and alignment workshops
  • Development of quality values and principles
  • Communication strategies for quality initiatives
  • Training programs for all organisational levels
  • Implementation of quality champions network
  • Metrics and recognition systems to reinforce quality behaviors
  • Compliance with ISO 13485 and ISO 9001

Get In Touch To Discuss Your Project

Book a meeting with a member of the IVDeology team

Send an email and let’s start discussing your project

Connect with us on LinkedIn and keep up-to-date with our news

Customer Case Study: Start up company looking for scalable QMS build with ongoing QARA maintenance support

Company Overview

A molecular diagnostic start-up approached us with the challenge of establishing a robust Quality Management System (QMS) that met the requirements of ISO 13485:2016.

Challenge

The customer required a comprehensive and scalable system for managing documentation, risk management, and compliance processes in line with ISO 13485:2016 whilst being affordable and flexible as they grow.

Solution

IVDeology’s internal QMS is managed by Cognidox, allowing our customers to feel confident in using the system, and being offered walk throughs and training of the system before implementation for staff competence and understanding of the systems use.

The project included providing templates that fit the customer needs as well as functionality training, documentation creation, initiation of certification body applications and management review meeting support.

Once we set the customer up with their eQMS, we could focus on supporting technical documentation structure within Cognidox which included file building within the system, reviews of any existing technical documentation, a roadmap for technical documentation towards the IVDR, and providing regular project meetings to track progress which allowed the company to feel supported, and keep to timelines and deadlines.

Results

We have supported this customer for several months, including further support to accelerate into other countries, providing regulatory strategies for worldwide markets to provide clear instructions for compliance and entry requirements. Having a team of both QA and RA specialists meant the customer could have full support from IVDeology with both the QMS implementation as well as regulatory support, which go hand in hand.