You are a manufacturer in the Medical Devices sector.
As a quality manager or director in the field of medical devices, you understand the importance of quality and compliance in ensuring the safety and efficacy of your products.
Strict regulations and rigorous standards demand precise and transparent management at every stage of the process.
Discover how the QUALIPRO modules, validated according to 21 CFR part 11, can assist you in implementing ISO 13485.
QUALIPRO module packs for the Medical Device industry.
- Meticulous Documentation.
- Corrective and Preventive Actions (CAPA)
- Management of Audits at Scheduled Intervals.
- Change Control
- Performance Indicators
- Risk Management
- Management of Non-Compliances / Deviations.
- Supplier Relationship Management
- Customers' Management
- Metrology Management
- Human Resources Management
- Effective Meetings.
- Regulatory Compliance.
Meticulous Documentation.
Simplify the management of your critical documents with our Electronic Document Management system.
Save time and reduce risks by eliminating errors related to the management of documents and records pertaining to medical device files.
Avoid mistakes and ensure traceability to meet the strict standards of the industry.
With an electronic validation and distribution system, compliant with 21 CFR part 11, you optimize your entire document management.
Corrective and Preventive Actions (CAPA)
Respond effectively to non-conformities and continuously improve your processes.
Identify problems, take corrective and preventive action, and ensure compliance.
All balance sheets and statistical reports are generated instantaneously, eliminating the need for time-consuming, repetitive data entry into Excels files. You’ll have reliable reports available in real time.
Management of Audits at Scheduled Intervals.
Automate the audit process to ensure regulatory compliance and process quality.
Plan, execute, and track audits with precision to uphold the integrity of your operations.
Generate your audit reports on the spot during your closing meetings. The concerned parties are automatically notified to plan and execute the necessary actions.
Your audit report is dynamic; it provides real-time status updates on actions resulting from the audit.
Change Control
Manage process changes accurately to minimize risks and ensure consistent quality and safety.
Track modifications from request to validation for proactive management.
Follow the lifecycle of changes, from request to validation, including analysis of potential impacts.
Performance Indicators
Measure and monitor key performance indicators to make informed decisions and enhance your manufacturing processes.
Track your indicators through CAPAs.
Automatically generate your dashboards.
Risk Management
Identify, analyze, evaluate, and mitigate potential risks to ensure the safety and performance of your medical devices.
Take preventive actions to maintain the integrity of your operations.
Management of Non-Compliances / Deviations.
Identify, track, and analyze non-compliances and deviations and eliminate them.
Furthermore, with Qualipro, you can initiate CAPAs to prevent the recurrence of these non-compliances and deviations.
Advanced reporting allows for thorough analysis of your deviations by type or workstation using frequency or significance measures (valuation of non-compliances).
Supplier Relationship Management
Foster strong partnerships with your suppliers by ensuring true mastery. Qualipro allows you to manage supplier information and their documentation, evaluate their performance, and ensure proper tracking of claims addressed to your suppliers.
Thanks to the SRM (Supplier Relationship Management) platform, coupled with Qualipro’s Supplier module, your supplier can respond online to their claims and can share their documents and certificates online.
Customers' Management
Strengthen your relationships with your clients by recording, tracking, and responding effectively to their requests and complaints.
With Qualipro, you can centralize information about your clients, conduct surveys, handle complaints, and maintain a high level of customer satisfaction.
Metrology Management
Ensure the accuracy of your measuring equipment in order to guarantee product quality.
Track calibration interventions and ensure traceability.
Human Resources Management
Your human resources are the cornerstone of your success.
Human Resource Management with Qualipro ensures that your team is skilled and motivated.
You can manage individual competencies, track training needs, and assess staff satisfaction.
This helps you effectively allocate skills, anticipate training needs, and maintain a fulfilling work environment.
Effective Meetings.
Optimize your meetings by planning, tracking, and executing decisions made for efficient follow-up and harmonious collaboration.
Regulatory Compliance.
Stay ahead of regulatory requirements to ensure compliance and avoid legal issues.
Choose the QUALIPRO module packs for transparent, efficient, and ISO 13485 compliant management while ensuring complete traceability of all operations (audit trail).
Contact us today to discover how QUALIPRO can help you maintain excellence in the medical device industry.