Importers’ readiness
Regular assessments, ongoing training, and close collaboration with regulatory authorities and stakeholders are crucial for importers….
Customized Services
Provide tailored support in finding a suitable manufacturer such as OEM & ODM & OBM, distributor or service provider meeting…..
Clinical evaluation- terms & process
Relationship of clinical data, clinical evaluation and clinical evidence and the process of clinical evaluation
Consider cybersecurity during procurement
Understand the level of support provided at each post-market phase of medical device ……
Reprocessing medical devices
Get an overview of the new regulatory requirements and liabilities for reprocessing medical devices
Continue sales even after the MDD certificate has expired
Summary of our practical and successful experience in bridging the regulatory gap by applying Article 97 of the MDR in a case study.
In-house Devices
In-house devices can be used in health institution without having to comply with most of regulatory provisions of EU MDR or EU IVDR…….
Extension of transition period for medical devices
Extend transition period for medical devices and delete “sell-off” deadline from the current EU MDR and IVDR
