MedTech Regulatory Affairs
Developing a robust regulatory strategy early in the product development process is crucial for efficiently advancing a medical device through its lifecycle. Our regulatory strategies can encompass the entire development and marketing journey of the device or focus on specific aspects such as device modifications or changing regulatory requirements.
Starting with defining the product's classification as a medical device in the target geographic market, determining applicable regulations and standards, and outlining the necessary testing strategies, a well-defined regulatory strategy sets a solid foundation for the project and helps avoid surprises down the road.
ReguLogix Consulting offers classification determinations for devices in any geographic location. Whether reviewing classification rules in the EU, Canadian, or Australian medical device regulations or searching the US FDA device classification database, our determinations are backed by years of experience and provide clear justifications for the chosen classification.
Additionally to the above, we can assist you in selecting Notified and Approved Bodies. We can provide information on which bodies offer CE or UKCA marking and identify those with the available capacity to accept new clients.
Starting with defining the product's classification as a medical device in the target geographic market, determining applicable regulations and standards, and outlining the necessary testing strategies, a well-defined regulatory strategy sets a solid foundation for the project and helps avoid surprises down the road.
ReguLogix Consulting offers classification determinations for devices in any geographic location. Whether reviewing classification rules in the EU, Canadian, or Australian medical device regulations or searching the US FDA device classification database, our determinations are backed by years of experience and provide clear justifications for the chosen classification.
Additionally to the above, we can assist you in selecting Notified and Approved Bodies. We can provide information on which bodies offer CE or UKCA marking and identify those with the available capacity to accept new clients.
Technical documentation encompasses all documents describing your device, and it is the manufacturer's responsibility to prepare for any device classification. This documentation should be managed within the Quality Management System (QMS) and regularly updated to ensure ongoing compliance throughout the product's lifecycle.
Producing clear and comprehensive technical documentation is essential for achieving expedited market access. Our approach follows the latest guidance to ensure all necessary information is included and organised for easy navigation, reducing review times and costs while facilitating faster approvals. This documentation serves as tangible evidence of your device's compliance with regulatory requirements and must be diligently maintained over the device's lifecycle.
ReguLogix Consulting plays a pivotal role in creating, updating, and remedying your technical files to ensure continuous compliance and the safe placement of your device in the market.
Producing clear and comprehensive technical documentation is essential for achieving expedited market access. Our approach follows the latest guidance to ensure all necessary information is included and organised for easy navigation, reducing review times and costs while facilitating faster approvals. This documentation serves as tangible evidence of your device's compliance with regulatory requirements and must be diligently maintained over the device's lifecycle.
ReguLogix Consulting plays a pivotal role in creating, updating, and remedying your technical files to ensure continuous compliance and the safe placement of your device in the market.
ReguLogix Consulting can assist you with various global pre-market submissions and product registrations, including:
- Pre-submission review meetings (such as Q-Subs, Pre-IDE, Pre-510(k), Submission Issue) and requests for designation (513(g)) with the FDA. The FDA pre-submission process is valuable for engaging with the FDA initially and obtaining feedback on development and regulatory review questions. We can help plan and execute the pre-submission meeting application, ensuring accurate information is provided, and relevant questions are posed to obtain desired feedback.
- International Dossier Submissions: We can support you in compiling and submitting product dossiers, such as Technical Files for UKCA/CE marking conformity assessment, eSTAR medical device submissions (510(k), PMA, De Novo, IDE) for FDA, and Medical Device Licence (MDL) applications for Health Canada, etc.
- ReguLogix Consulting collaborates with in-country representatives to decipher regulatory agency requests and provide the most relevant information available. We have recent experience assisting with registrations in various territories worldwide, including Australia, India, Brazil, the Middle East, South Korea, Israel, Malaysia and more.
In today's ever-evolving regulatory landscape, manufacturers are increasingly responsible for demonstrating proactive post-market monitoring of their products. Establishing robust post-market surveillance systems to collect data is essential to ensuring continued product safety and efficacy while minimising risks to end-users.
ReguLogix Consulting specialises in assisting manufacturers with maintaining compliance during the post-market phase. We can help you develop a tailored plan to fulfil your regulatory obligations throughout your product's lifecycle, supporting its safety and effectiveness after market launch.
Additionally, we provide expert regulatory change assessments to streamline the process of reporting changes to your certifying Notified Body or Regulatory Agency. Our independent evaluations ensure that only substantial changes are reported, helping you avoid unnecessary reviews, reduce costs, prevent project delays, and maintain operational flexibility.
Trust ReguLogix Consulting to navigate post-market regulatory requirements and optimise your product's compliance and performance.
ReguLogix Consulting specialises in assisting manufacturers with maintaining compliance during the post-market phase. We can help you develop a tailored plan to fulfil your regulatory obligations throughout your product's lifecycle, supporting its safety and effectiveness after market launch.
Additionally, we provide expert regulatory change assessments to streamline the process of reporting changes to your certifying Notified Body or Regulatory Agency. Our independent evaluations ensure that only substantial changes are reported, helping you avoid unnecessary reviews, reduce costs, prevent project delays, and maintain operational flexibility.
Trust ReguLogix Consulting to navigate post-market regulatory requirements and optimise your product's compliance and performance.
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