Custom Software Solutions for Your Quality Management System

We specialize in:

• Developing custom software tools and integrations that align with your operational needs
• Solution:

• SAP

• Polarion

• SmartSolve

• IBM Doors

• Automating processes to reduce manual errors, save time, and improve traceability
• Ensuring smooth interoperability between tools like SharePoint, Jira, and Confluence to create a cohesive QMS ecosystem
• Building custom cloud-based solutions tailored to your QMS requirements, enabling secure access, scalability, and seamless collaboration across teams

Why Work With Us?

• Proven Expertise in Medical Device QMS Solutions

  We have developed a complete design control software integrated with a custom-built Risk Management Tool, enabling efficient management of technical documentation and risk management. This solution was successfully used to achieve Class IIa medical device certification, audited by TÜV SÜD

• Advanced Document Management Solutions

  We’ve built internal document management tools for large medical device companies, helping them manage complex documentation processes across multiple departments with ease

• Practical and Tailored Approach

  Every solution we build is designed to meet your company’s specific workflows, ensuring the system works for your team while staying compliant with regulations

Our Regulatory and Industry Expertise

At QMLogic, we come from a medical device software and regulated environment, so we understand the critical importance of compliance and security

• Extensive Experience with QMS Standards and Validation

  We have built multiple QMS systems from scratch, giving us in-depth knowledge of:
• ISO 13485
• FDA 21 CFR 820
• Part 11 requirements for electronic signatures

• Regulatory-Compliant Tool Validation

  Our solutions adhere to strict requirements for Software Tool Validation, ensuring your tools are both secure and compliant with international regulations

• Control of Documents and Records

  We design systems that meet all requirements for the control of documents and records as required by ISO 13485, ensuring traceability, security, and audit-readiness
• With QMLogic, you can be confident that your QMS ecosystem will remain secure, streamlined, and fully compliant with regulatory standards

• ISO 27001 Expertise and Data Security

  At QMLogicQMLogic, we understand the critical importance of data security in regulated environments and apply the principles of ISO 27001 in every solution we build
• We have in-depth knowledge of ISO 27001 and ensure it is applied to protect the confidentiality, integrity, and availability of your data
• Our custom solutions allow your data to remain fully under your governance and can be hosted entirely on your own servers, ensuring maximum control if desired
• We implement and enforce strict access management policies, ensuring only authorized personnel can access sensitive information, aligning with both ISO 27001 and other regulatory requirements

With our expertise, you can be assured that your QMS ecosystem is not only operationally efficient but also secure and compliant with the highest data security standards.