Accelerate with IVDeology
Accelerate your route to market by utilising IVDeology’s experts as an extension to your technical team. Together we will navigate the regulatory pathway efficiently and cost-effectively, inclusive of upskilling & in-house training options for your team.
Accelerate Market Access for your Product
Regulatory
Strategy
Optimise your regulatory pathway with our strategic planning approach. We help you in identifying the most efficient route to market based on your specific IVD product and target markets.
Quality
Plan
Support with documented planning that outlines quality policies, procedures and guidelines for projects and/or facilities while establishing quality expectations and metrics.
Expert
Advice
Benefit from access to the IVDeology’s team of regulatory and quality experts who provide targeted guidance at any part of your development and approval process.
Technical
Review
A comprehensive review of your technical documentation before final submission, identifying and addressing potential issues that could cause delays.
Regulatory Strategy
A well-designed regulatory strategy is the foundation for efficient market access, providing a clear pathway that both optimises resources and minimises potential delays. Our strategic approach includes:
- Comprehensive product and technology assessment
- Regulatory classification analysis for UK, EU and US markets, plus other territories
- Risk-based pathway determination
- Conformity assessment procedure selection
- Identification of applicable standards and requirements
- Gap analysis against regulatory requirements
- Strategic planning for multiple market access
- Timeline development with critical path analysis
Quality Plan
Quality planning supports safe and effective diagnostics ultimately being available to patients and consumers, plus demonstrates your commitment to quality excellence. Our Quality Plan approach includes:
- Development of tailored Quality Management System (QMS) documentation
- Risk management implementation across design and manufacturing processes
- Design control procedures and verification protocols
- Process validation methodologies for manufacturing
- Supplier qualification and management systems
- Quality control testing strategies and acceptance criteria
- Internal audit planning and management review processes
Expert Advice
Access IVDeology’s team of regulatory and quality experts who provide targeted guidance at critical points in your development and approval process. Our Expert Advice services include:
- IVD Regulatory Framework Advice
- Classification & Conformity Guidance
- Notified Body Interactions Support
- Advisory Sessions
- Development Support
- Strategy Workshops
- Technical Reviews
Technical Review
IVDeology’s thorough pre-submission process identifies and addresses potential issues that could impact approval timelines. The Technical Review includes:
- Comprehensive technical documentation assessment
- Verification of regulatory requirements alignment
- Gap analysis against applicable standards
- Evaluation of performance and clinical evidence
- Risk management file review
- Labeling and IFU compliance check
- Post-market surveillance plan assessment
- General safety and performance requirements verification
Get In Touch To Discuss Your Project
Book a meeting with a member of the IVDeology team
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Customer Case Study: Supporting our customer with implementing a flexible and reliable QMS with a long term regulatory strategy
Customer Overview
This start-up company, working on developing a professional-use system and a software device sought our support in building their QMS in compliance with ISO13485 requirements.
Challenge
The customer found it challenging to find support in developing their QMS that was in budget and personalised to their business needs, compared to systems that were too expensive and too advanced for what they needed at the stage of the company and business. This is where IVDeology came in.
Solution
It was important for us to support our partner not only with QMS acceleration, but with a regulatory strategy build for a clear pathway of market access requirements. Not only did this allow them to understand what they needed to do to place devices in their short term target
markets, the document is an IVDR requirement for access into the EU market, and therefore puts them in good stead for CE marking in the future.
As a key point of their regulatory strategy was us providing information on the USA market access requirements, we felt important to work on a FDA pre-submission, to support a future 510(K) submission. As a result, we facilitated a productive meeting between the start-up company and the FDA.
Results
The customer gained their pre-sub documentation successfully. This was an important piece of their regulatory strategy, as it allowed the customer to understand the FDA’s expectations of specific elements within the design and development of their device. This is critical in enabling a ‘right first time’ approach to their eventual 510(k) submission. We are still supporting the customer as we move into the technical file building stage, and has meant proceeding toward the 510k submission should be less time consuming, less room for error and a clear route to market plan.
Case Study: Helping a Start-Up IVD Company Accelerate into worldwide market
Company Overview
A start-up company in the early stages of developing an In Vitro Diagnostic (IVD) device reached out to IVDeology for guidance on how to navigate the complex landscape of quality and regulatory compliance. Their goal was to accelerate the development process, and map out a market access plan quickly and effectively.
Challenge
As a newly established company, the client faced the challenge of understanding the intricate and evolving regulations in different global markets. They needed expert guidance to ensure their products complied with regulatory standards in the UK, EU, USA, and other international markets. The client also wanted to accelerate their path to market and minimize the risk of costly missteps during product development.
Solution
Recognising the importance of a strong regulatory strategy, we worked closely with the client to ensure compliance with IVD regulations across the identified markets.
To help the company gain a clearer understanding of their market access requirements, we implemented the following solutions:
- Regulatory Strategy Development: We developed a comprehensive regulatory strategy document that outlined the regulatory requirements for the client’s target markets, including essential requirements for Quality Management Systems (QMS). This strategy not only addressed the EU IVDR requirements but also provided an in-depth view of the regulatory landscape in other key markets, including:
- GB
- Northern Ireland
- USA
- Australia
- Brazil
- Canada
- Japan
- Market Access Support: The strategy served as a valuable tool for the client’s team, enabling them to understand the regulatory requirements specific to each market.
- Funding Support: With a clear regulatory pathway outlined, the client was able to leverage the strategy for potential funding opportunities, presenting a structured plan that demonstrated both market entry and compliance.
- Risk Reduction: We provided the client with the tools and knowledge needed to plan both short-term and long-term actions, helping them avoid costly and time-consuming processes like clinical performance evaluation studies. By understanding the regulatory requirements in advance, they could make informed decisions to streamline their development process.
Results
The regulatory strategy proved to be a game-changer for the start-up, providing the following benefits:
- Clear Path to Market: The client gained a solid understanding of the regulatory requirements needed to enter their target markets, ensuring faster and more efficient market access.
- Funding Opportunities: With a well-defined strategy, the client was equipped with the necessary supporting documentation to pursue funding, which helped drive their business growth.
- Reduced Risk and Cost: The strategy allowed the client to anticipate and avoid the risk of repeating costly activities, such as unnecessary clinical performance evaluations, saving both time and money.
- Strategic Planning: The client now has the necessary framework to plan their short-term and long-term regulatory activities, minimizing risks and maximizing their ability to move quickly and effectively in the market.