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Three tools that help medical device SMBs work remotely
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- Understanding post-market surveillance requirements for medical devices (US & EU markets)
- Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
- Biomarkers as drug development tools: discovery, validation, qualification and use
- Clinical Biomarkers in Drug Discovery and Development
- Non-Inferiority Clinical Trials to Establish Effectiveness
- FDA Approval Process
- Three tools that help medical device SMBs work remotely
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Three tools that help medical device SMBs work remotely
[/vc_column_text][vc_column_text]UK employees who wish to work remotely at least one day a week have increased to 86 %. New to remote working, small and medium-sized businesses (SMBs) have found it difficult, particularly in medical device manufacturing. While navigating the regulatory clearance process, companies must adjust to new arrangements.
Although the COVID-19 epidemic has imposed restrictions on the medical device sector, such as restricting on-site inspections, the regulatory process has not slowed. The US Food and Medication Administration stated in June 2020 that it had met its goal of assessing at least 90% of brand, generic, and biosimilar drug applications during the pandemic. This means that producers must devise new methods for efficiently navigating the approval procedure while operating outside the office or laboratory.
Greenlight Guru
One of the most challenging issues for productions seeking regulatory approval is simplifying quality processes to minimize its time to bring a product to market. Companies have traditionally relied on paper-based methods to track quality, which users sometimes find challenging to organize and retrieve particular data when needed. Greenlight Guru was launched in 2013 as the first digital eQMS to automate and streamline the QMS process to avoid these problems.
JIRA
Greenlight Guru merged its platform with project management software JIRA in 2018 to improve product development and post-market quality management easier for manufacturers. JIRA allows users to construct roadmaps that outline all ongoing projects, allowing manufacturers to properly plan and manage all parts of the regulatory process and track progress against deadlines. This might entail creating a table of contents or gathering design and development information for your product.
AssurX
AssurX is a flexible programme that allows manufacturers to collaborate and interact with one another. It can create electronic workflows of tasks, notifications, and approvals, and it employs dashboards to offer live views of all activities in various sections of the organization. This permits you to keep on top of the regulatory process and will enable you to overcome any communication gaps when working remotely.[/vc_column_text][vc_column_text]
References
Moultrie, James, Laura Sutcliffe, and Anja Maier. “A maturity grid assessment tool for environmentally conscious design in the medical device industry.” Journal of Cleaner Production 122 (2016): 252-265.[/vc_column_text][/vc_column][/vc_row]
