Get Life-Saving Devices to Market Faster with Solutions for Medical Device Quality

Reactive Quality Management

Recalls within the medical device industry pose significant challenges. They result in financial and reputational threats and serious risks to patient safety. Companies that take a reactive approach to quality management may only address issues after they’ve occurred, rather than tackling them before they result in post-market events. 


Lack of Supply Chain Visibility

Lack of end-to-end visibility in the medical device supply chain can lead to traceability issues, delayed products and threats to product quality. Supply chain visibility is critical for effective supplier management, traceability and collaboration.

Using Disparate Processes

Quality can’t be managed effectively in a silo. Siloed or disparate processes result in a lack of standardization across the organization, which can result in noncompliance with industry standards and regulations. Disparate processes can also lead to poor communication across departments, like R&D, manufacturing, and quality.

Proactive Quality Management

Don’t react to adverse events, prevent them from occurring in the first place. Dot Compliance’s eQMS helps medical device organizations take a proactive approach to quality, so you can tackle quality events before they threaten patient safety.

Quality and Compliance Enforcement Across the Entire Supply Chain

With Dot Compliance eQMS solutions, you can manage and automate your entire quality ecosystem within a single source of truth. Promote collaboration and ensure your organization and outsourced suppliers get the required visibility in real-time from early product development – design history files (DHF) and device master records (DMR), manufacturing – to post-market surveillance.

Connected Quality and Regulatory Enforcement

Dot Compliance’s cloud-based, end-to-end quality management solutions mitigate risks and ensure visibility and traceability. They integrate data from the beginning of the design cycle, to manufacturing, all the way to post-market surveillance—all while ensuring compliance with regulations such as 21 CFR Part 11, 21 CFR Part 820, GMP, ISO13485, ISO9001, and others.

See the #1 eQMS for the medical device industry  in action.