Medical Device QMS Software

Medical device QMS software is a digital application designed for medical device companies to manage their Quality Management System (QMS) processes in an efficient and compliant manner.

QMS software enables users to centralize quality-related documents and records, simplifying access and information sharing across various departments and team members.

Comprehensive medical device eQMS solutions, such as SimplerQMS, encompass all aspects of quality management, ranging from document control to change control, design control, training management, nonconformance management, CAPA management, supplier management, and more.

Medical device QMS software supports all QMS processes, helping ensure compliance with requirements set by regulatory authorities, such as FDA and EMA.

Medical device and Medtech companies use QMS software for several key reasons, as listed below.

• Compliance and Regulatory Requirements: Medical device companies operate in a highly regulated environment. QMS software helps ensure compliance with standards and regulations such as ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, and others.
• Efficiency and Process Improvement: QMS software significantly improves internal efficiency by automating routine tasks and streamlining workflows.
• Product Quality and Risk Management: The QMS software aids in risk assessment, managing nonconformances, and conducting thorough quality audits to ensure high and uniform product quality.
• Customer Satisfaction and Market Competitiveness: Medical device QMS software helps track customer feedback, efficiently manage complaints, and support post-market surveillance. The continuous feedback loop and improvement help companies stay competitive and responsive to market needs.
• Data Integrity and Security: The medical device QMS software enforces data encryption, manages access controls, and maintains data integrity. The QMS software system protects sensitive patient and product information, ensuring data is accurate and reliable for decision-making.

Various departments within a medical device company can benefit from medical device QMS software, as listed below.

• Research and Development (R&D): R&D teams benefit from medical device eQMS by enhancing innovation through better management of design controls and risk assessments. R&D engineers, product developers, and project managers utilize the software to manage design history files (DHFs) device master records (DMRs), and Technical Files (TF), streamline the design and development process, ensuring compliance with design control requirements.
• Quality Assurance (QA): Quality Assurance departments leverage medical device QMS software to ensure product quality and regulatory compliance, mitigating risks and errors. QA specialists rely on the software to manage audits, non-conformances, CAPAs, and other processes to ensure adherence to applicable requirements.
• Manufacturing: Manufacturing departments use QMS software to optimize production processes, manage quality control, ensure product traceability, and support product realization. Production supervisors, process engineers, and quality control inspectors benefit from process monitoring and quality control, including the management of Product Release Notes (PRN) and Batch Master records (BMR).
• Regulatory Affairs (RA): Regulatory Affairs departments depend on medical device QMS solutions to ensure compliance with national and international medical device regulations and customer requirements. Regulatory specialists and compliance managers use the software to manage regulatory submissions and manage compliance documentation.
• Human Resources (HR): HR departments use an eQMS to manage training and certification programs and support compliance with regulatory and customer requirements. HR managers and training coordinators leverage the QMS software to track employee certifications, training schedules, and compliance with training requirements.
• Customer Service: Customer Service departments benefit from QMS software by enhancing the quality of customer interactions and ensuring quick resolution of customer complaints. Customer service representatives, technical support specialists, and customer relationship managers use the QMS software to access comprehensive product information, manage customer complaints, and track service requests.

Choosing a medical device QMS software involves several steps to ensure it meets the company’s unique needs. The steps companies can follow to choose quality management software are listed below.

1. Assess Requirements: Determine the company’s regulatory compliance requirements and key QMS software features.
2. Research and Compare Vendors: Use Requests for Information (RFI), Requests for Quotation (RFQ), and Requests for Proposal (RFP) to collect information from vendors, comparing features and various aspects.
3. Select Relevant Vendors: Select vendors that match the company’s needs, considering their reputation, offered services, and customer reviews.
4. Request Demos and Meetings: Assess the suitability of QMS software through demos and meetings with selected vendors.
5. Consider Trial Period: Test the QMS software for functionality, ease of use, and compatibility with current workflows during the system trial period.
6. Shortlist Vendors: Shortlist vendors based on demos, meetings, and trial results.
7. Request Use Case Demonstrations: Ensure the QMS software suits daily operations by requesting specific use case demonstrations.
8. Negotiate Terms: Discuss pricing, contracts, and implementation details with shortlisted eQMS providers.
9. Make Final Decision: Evaluate all information, including demos, trials, and negotiations, to select the best QMS software solution.

The best QMS software for the medical device industry depends on the unique needs and requirements of each company. Factors such as company size, regulatory requirements, budget constraints, and specific operational needs influence the choice of QMS software.

Medical device manufacturers select SimplerQMS as their preferred QMS software because of its comprehensive features tailored to Life Science needs.

SimplerQMS provides comprehensive QMS support with all modules, such as document control, training management, change control, design control, audit management, nonconformance management, CAPA management, equipment management, product lifecycle management, and others.

SimplerQMS QMS software is fully validated according to ISPE GAMP 5. SimplerQMS helps companies achieve and maintain compliance with requirements such as ISO 13485:2016, MDR, IVDR, 21 CFR Part 820, and others. The QMS software provides 21 CFR Part 11 and EU Annex 11 compliant electronic signatures, ensuring the authenticity, integrity, and confidentiality of electronic records.

The eQMS solution also offers integration options with various systems, such as Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Customer Relationship Management (CRM), and Product Lifecycle Management (PLM).

SimplerQMS is different from other QMS software solutions in several important ways. Below are 10 reasons why SimplerQMS is unique.

1. Seamless Microsoft Office 365 Integration: Work effortlessly in Microsoft Office applications, such as Word, Excel, and PowerPoint, while editing documents in SimplerQMS.
2. Use Your Existing Forms and Documents: Keep using your forms and templates in the familiar Word and Excel format in SimplerQMS. We help you migrate documents and other files, so you don’t have to recreate your documentation in SimplerQMS.
3. Full Validation: SimplerQMS is fully validated according to ISPE GAMP 5 and complies with FDA 21 CFR Part 11, EU GMP Annex 11, and ISO 13485:2016 requirements. We provide continuously updated validation evidence, including full Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
4. Unlimited 24/7 Support: SimplerQMS provides comprehensive customer support around the clock with no extra charges. Contact us via email, phone, video calls, support portal, or online knowledge base, and we’ll assist you without tracking hours.
5. Integrated Life Science QMS Modules: Access all QMS modules at no extra cost, including document control, change management, training management, design control, nonconformance management, CAPA management, and more.
6. Configurable Metadata and Reporting: Tailor metadata information to support best practices and easily report on your data with built-in or customizable views.
7. Expertise in Life Science Processes and Audits: Benefit from our extensive experience in regulatory audits and inspections. We comply with FDA 21 CFR Part 11 and 820, EU GMP Annex 11, ISO 13485:2016, and more.
8. No Charge for Onboarding: Our subscription includes all services, such as onboarding, implementation, training, validation, hosting, and support. The yearly license cost includes live online training, on-demand videos, and a sandbox training environment.
9. Enterprise-Grade Infrastructure and Services: Enjoy enterprise-grade infrastructure with Single Sign-On (SSO) across Windows, Mac, and mobile devices through Microsoft Entra ID. Our ISO 27001:2022 and SOC 2/3 compliant Microsoft Azure hosting ensures reliability and compliance.
10. Wide Integration Support: Use our modern API or plugins to integrate seamlessly with other systems, such as ERP, CRM, PLM, LIMS, and more.

The QMS software by SimplerQMS is usually implemented within 5 to 6 weeks.

The time needed for QMS software implementation can vary depending on factors such as the number of documents to be created or migrated and the company’s available time resources.

SimplerQMS software implementation follows a structured phase approach, focusing on deploying specific QMS modules in each phase. SimplerQMS enables flexible module sequences to meet individual needs, with all implementation activities and associated training included at no additional cost.

SimplerQMS quality management solution pricing starts at $13,750 or €12,500 per year for approximately 10 users. The total cost depends on the types and number of licenses required.

The yearly license fee includes all medical device QMS modules, system implementation, user training, ongoing support, validation, and cloud hosting.

The SimplerQMS pricing structure is based on the number of licenses purchased, and it covers all features and services without extra costs.

Please visit our pricing page for detailed information on costs, features, and services provided.