Design Control
Clinical Evaluation &Clinical Trials
Support in planning, conducting, and reporting clinical evaluations and clinical trials in compliance with regulations.
Risk Management
Assistance in identifying, assessing, and managing risks according to standards.
Product Lifecycle Management
Support with changes, modifications, and renewals of existing product approvals throughout the lifecycle.
Software and Digital Health
Specialised services for software as a medical device (SaMD) and digital health products, including regulatory strategy and compliance.
Design History File
A design history file (DHF) is a collection of documents that records the design and development process of a medical device. It provides evidence that the device meets the regulatory requirements and user needs. A DHF is required by the FDA and other regulatory bodies for medical device approval.
We can help you create, maintain, and update your DHF throughout the product lifecycle. A DHF consultancy service can also help you with audits, inspections, and compliance issues. A DHF consultancy service can offer you expert guidance, best practices, and customized solutions for your specific device and market.
Risk Management
Risk Management helps medical device manufacturers and developers to identify, assess, and mitigate the potential risks associated with their products.
Risk Management consultancy services can help to ensure compliance with regulatory standards, enhance product quality and safety, and reduce liability and costs. We can provide expert guidance on risk analysis, risk evaluation, risk control, risk monitoring, and risk reporting throughout the product lifecycle.
New Product Development Support
If you are developing a new medical device, you need to comply with the regulatory requirements of your target market.
This can be a complex and time-consuming process, especially if you are not familiar with the specific regulations and standards. That’s why we offer a comprehensive regulatory consultancy service for medical device manufacturers. We can help you with every stage of the product development cycle, from design and testing to documentation and submission. We have extensive experience and expertise in the medical device industry, and we can provide you with tailored advice and guidance to ensure your product meets the highest quality and safety standards.
Whether you need assistance with CE marking, FDA approval, ISO 13485 certification, or any other regulatory requirement, we can help you achieve your goals faster and more efficiently.
Contact us today to find out how we can support your new product development.