We help you to verify the classification of your medical device and pick the relevant conformity assessment process in your targeted market areas. We then help you to identify the standards that are applicable to your medical device and draw you a roadmap of the activities that are required from you prior and after the market approval.
We are here to ensure the smoothest way for your medical device to the market.
Quality Management System for Medical Device Manufacturers
We help you to build a Quality Management System (QMS) that is in alignment with the internationally recognized ISO 13485 standard and the US FDA Quality System Regulation (QSR), as well any other applicable regulations and standards. Yet, the QMS will be customized for your business needs.
A well structured QMS supports you with the daily activities and ensures the continuous high quality of your medical devices. If you need help with an existing QMS, we can perform an audit to find the gaps and work together with your professionals to fill them. The same applies, if there are new regulations or standards you need to consider.
Quality and Regulatory Manager Services
If needed, we can take the role of a Quality Manager in your company.
Also, the global regulations require that a company has a person, who is responsible for regulatory compliance, and who holds sufficient competence for this job. A small organisation is allowed to outsource this person and Lean Entries can fill the position.
Internal and External Auditing
We help you perform the periodical internal audits and supplier audits to ensure your own processes and any subcontracted ones are in compliance with the regulatory requirements. We can also support you to prepare for an audit by the certification bodies and authorities and will help you with addressing their audit findings.
Understanding the regulatory requirements at an early phase of a product development process is essential. This ensures, that from the very beginning, all activities focus on placing the device efficiently on the market.
We can help you define and implement a product development process that is in compliance with the regulations of the target market. These might be the European MDR or IVDR, US FDA requirements, the international ISO 13485 for a QMS, IEC 62304 for Software Life Cycle, IEC 62366 for Usability of medical devices, and many more. The development process starts off by drafting a Product Development Plan that identifies all activities and documents required throughout the project.
Risk Management is a process that continues throughout the entire lifecycle of a medical device and is addressed in the international ISO 14971 standard. We can establish a Risk Management process for your company and a Risk Management file for your product accordingly.
We will guide you through the best Risk Management practices and help you to define the Benefit-Risk ratio for the device.
Clinical Evaluation validates the clinical safety and performance of a medical device when it is used as intended by the manufacturer. This is achieved by identifying, appraising and analysing all available and relevant clinical data, starting from a comprehensive literature and database searches on existing data. Clinical Evaluation, just like Risk Management, is an ongoing process throughout the life cycle of the medical device.
We help you to plan and perform the Clinical Evaluation and the Post-Market Clinical Follow-up for your device, define the need for Clinical Investigations and compile the conclusions into a report according to the regulations and global state of the art guidelines.
Beyond Risk Management and Clinical Evaluation reports, we help you to compile the remaining Technical Documentation for your device and ensure it complies with international standards and guidelines. This includes planning the needed verification and validation activities for your product to cover the safety and performance requirements of the global regulations. As an end result, your Technical Documentation can be utilized to access the global markets, be it the CE mark in EU, the 510(k) Premarket Notification in the US, or another ticket into a specific market.