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.
Author: joomir
GAP Analysis Services
As an initial step, we highly recommend that manufacturers perform a thorough Gap Assessment against any new regulations (or standards, guidelines, etc.). This allows the company to develop a regulatory strategy to fulfill its obligations and ensure ongoing compliance. We offer gap analysis services to support you in this process.
Quality Management System Setup
Complete setup of your QMS to fit the scope and role of your organisation. As a minimum, this service includes the Quality Manual and major quality procedures which may be used as a foundation to develop the system further. Offer retraining to your employees to keep your QMS up to date and ensure proper document maintenance.
Regulatory Updates
Keeping clients informed about changes in relevant regulations and standards and helping them adjust their strategies or processes accordingly.
Risk Management
Ensuring that risk management practices are in place, helping to identify, assess, and mitigate potential risks throughout the medical device’s lifecycle.
Inspections
Conduct an objective internal audits of clients as an independent third-party auditor, providing guidance on identifying gaps and opportunities for improvement.
Regulatory Audits and Inspections
Preparing clients for regulatory audits or inspections, ensuring that the company’s systems, documentation, and processes meet regulatory requirements
Post-market Surveillance
Advising on post-market obligations, including adverse event reporting, vigilance requirements, and monitoring the device’s performance once it’s in the market.
Labeling and Documentation
Ensuring that the device labeling, including instructions for use (IFU), complies with regulatory requirements and includes all necessary warnings, contraindications, and other important information.
Writing Technical file for Class I and II medical devices according to EU MDR
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
Compliance with Standards
Advising on compliance with applicable international and regional standards such as ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management).
Regulatory Submissions
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.