The marketing approval process for medical devices refers to the process of gaining approval or clearance from regulatory authorities to sell and distribute the devices in various markets. This process involves navigating regulatory requirements, demonstrating safety and efficacy, and sometimes also requires compliance with standards or quality system requirements specific to each market. Country specific post market surveillance procedures are often required to be a part of the company QMS.
CE-marking and/or FDA approval for example , plays a crucial role in ensuring that the devices can be legally marketed and distributed within the European Union (EU)/European Economic Area (EEA) and the US. Approval in EU or US can also supports approval in many other markets.
Our team give educational and tailored support to your company and products, whether it’s developing overarching strategies or addressing specific areas, such as;
- Activities related to design and development.
- Implementation and maintenance of Quality Management Systems (QMS) compliant with ISO 13485, EU MDR and/or US QSR 820.
- Performance of clinical evaluation to demonstrate safety and performance of the device(s).
- Develop and review technical documentation such as design documentation, risk management, clinical evaluation reports, labeling and manufacturing information.
- Identification of conformity assessment route based on the classification of the device and regulatory requirements and activities include auditing, testing, and review of technical documentation.
- Activities related to national and/or global registration including submissions in various systems (e.g. Eudamed, MHRA)
- Post-Market Surveillance (PMS) to monitor the device’s performance and safety.
- Device Lifecycle Management, design changes, technical documentation updates, address regulatory updates/changes and end-of-life processes.
Contact us for further information
Our team can assist your organization in attaining compliance while boosting productivity within your organization. Contact us here if you have any questions or want to learn more about how we can support.
Read more about …
– Clinical evaluations and Performance evaluation
– Risk Management
– Software and Cybersecurity
– Biocompatibility assessment
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
