Regulatory Intelligence (RI) services

Want to know about regulation changes for your device?

Regulatory requirements are always evolving. That means maintaining compliance and staying informed of changes is paramount for companies in the medical device industry. At LFH Regulatory, we offer comprehensive regulatory intelligence (RI) services. Our services are designed to help manufacturers navigate the complexities of medical device regulation with confidence and efficiency.  

Understanding Regulatory Intelligence (RI)

Regulatory intelligence (RI) is a systematic process of collecting, analysing, and issuing information about regulatory requirements, policies, and guidelines that impact the development, manufacturing, distribution, surveillance, and regulation of medical devices.

Our RI services are tailored to provide manufacturers with the insights and information they need to make informed decisions and ensure compliance throughout the product lifecycle. 

Why Regulatory Intelligence Matters

Manufacturers:

Regulatory intelligence equips manufacturers with the latest information needed to make strategic decisions. From deciding which medical devices to develop to determining market entry strategies and estimating regulatory compliance efforts and costs, RI empowers manufacturers to navigate complex regulatory laws and processes.

Healthcare Providers:

Healthcare providers rely on regulatory intelligence to make informed decisions about buying and operating medical products. They use regulatory information to assess the safety, performance, and availability of medical devices, ensuring compliance with legal requirements and providing the best care to patients.

Authorities and Notified Bodies:

Regulatory agencies and notified bodies utilise Regulatory Intelligence to prepare employees for future regulatory requirements, inform manufacturers about upcoming changes, and ensure the conformity of products and manufacturers during approval and market surveillance processes.

Clinical Researchers:

Clinical researchers depend on regulatory intelligence to understand regulatory requirements, select markets for clinical investigations, and plan and conduct trials in compliance with regulatory standards. RI helps streamline the research process and ensure adherence to regulatory guidelines.

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Monitoring Changes in Medical Device Regulation

Our RI services begin with understanding the current regulatory landscape and predicting changes that may impact our clients’ businesses. We watch regulatory developments at both a global and local level, keeping our clients informed about upcoming changes and guiding them through the necessary steps to support compliance. 

Goals of Regulatory Intelligence

The primary goal of regulatory intelligence is to provide stakeholders with timely and relevant information to support informed decision-making.  For manufacturers, RI serves several key aims, including:

  • Deciding on the development of medical devices.
  • Deciding market entry strategies and regulatory requirements.
  • Assessing the impact of planned regulations and estimating compliance efforts. 
  • Ensuring the availability of skilled staff and necessary resources.
  • Planning and organising additional resources for regulatory compliance 

Main Stages of Regulatory Intelligence Activities

  • Information Gathering: We systematically collect regulatory information from various sources, including standards, global regulations, guidance documents, and industry news.
  • Analysis and Interpretation: Our team of experts analyses the gathered information to find relevant updates, changes, and trends that may affect our clients’ products or operations.
  • Dissemination: We provide clear and concise summaries of regulatory updates, along with actionable insights and recommendations, to ensure our clients are well-informed and prepared to take appropriate actions.

We understand the challenges that manufacturers face in developing a comprehensive and robust regulatory intelligence framework. Some common challenges include: 

  • Adapting to rapidly changing and complex regulations.
  • Uncertainty and access to regulations in emerging markets.
  • Spending too much time researching regulatory requirements for different countries.
  • Regional legislation is often in local languages. Insufficient coordination and compilation of information from multiple functions.
  • Unstructured information results in regulatory intelligence not being used appropriately.
  • Lack of a centralised mechanism to capture regulatory intelligence. 

 

At LFH Regulatory, we address these challenges by using our ability, resources, and technology to provide prompt, accurate, and actionable regulatory intelligence solutions.

Additional Services

As a full-service Medical Device Compliance Consultancy, we offer a suite of additional services:

Expertise and Experience

Our consultants possess extensive knowledge of regulatory requirements and are well-versed in the intricacies of the medical device industry. With our expertise, we guide you through the compliance process, reducing risk and ensuring successful market access.

Regulatory Strategy Development:

We collaborate closely with you to develop a tailored regulatory strategy that aligns with your business goals. Our experts assess your device portfolio, identify regulatory requirements, and assist in implementing strategies for successful market access.

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