Regulatory

The manufacturer is required to provide the user or patient with appropriate information such that the product can be used both safely and effectively throughout its lifetime.
Labelling mistakes can be very costly and we understand that all these requirements can sometimes be difficult to keep up with. Let us have a look at your labels or instructions for use and we will let you know what’s missing and where you can improve.
You may also contract us to develop a regulatory plan for meeting your labelling and IFU requirements. We will provide you with a document detailing exactly what information should be placed on your device / packaging / IFU and which international symbols should be indicated.

Keeping clients informed about changes in relevant regulations and standards and helping them adjust their strategies or processes accordingly.

Ensuring that risk management practices are in place, helping to identify, assess, and mitigate potential risks throughout the medical device’s lifecycle.

Conduct an objective internal audits of clients as an independent third-party auditor, providing guidance on identifying gaps and opportunities for improvement.

Preparing clients for regulatory audits or inspections, ensuring that the company’s systems, documentation, and processes meet regulatory requirements

Advising on post-market obligations, including adverse event reporting, vigilance requirements, and monitoring the device’s performance once it’s in the market.

Ensuring that the device labeling, including instructions for use (IFU), complies with regulatory requirements and includes all necessary warnings, contraindications, and other important information.

Guiding clients in collecting and analyzing valuable data and necessary report to demonstrate the device’s safety and effectiveness, including creating clinical evaluation reports (CERs) ,Usability Engineering files , design file, Engineering validation and ensuring compliance with require regulations for marketing authorization in Europe

Advising on compliance with applicable international and regional standards such as ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management).

Preparing and submitting regulatory documents for market approval, such as 510(k) submissions (in the U.S.), Technical Files, or Design Dossiers (in the EU), depending on the region is one of our specialties.

Determining the correct class of your device could speed up the process of your approval in your target market such as the USA, Europe and Canada. We classify your device based on risk and intended use correctly.

Finding a regulatory pathway is a key item in marketing your device as it could impact the wait time for receiving the marketing authorization, reducing the cost. Here in Quality Professionals Inc we design the appropriate pathway and identify the necessary approval for FDA, CE marking and MDSAP for Health Canada by providing you with Regulatory Affairs Consulting.