Unlock Over 25 Years of Expertise

At Wismatix, we bring you over 25 years of unmatched experience in designing, implementing, and operating cutting-edge management systems. Our expertise caters to businesses of all sizes in the service, development, and production sectors, equipping them with the tools to excel.

We specialize in creating standardized systems that meticulously document procedures, processes, and responsibilities, aligning with your quality policies and objectives. Our solutions empower you to manage your data with unprecedented efficiency, enabling you to meet and surpass your customers’ and regulatory authorities’ expectations.

Join Millions Worldwide Benefiting from QMS Standards

Implementing Quality Management System (QMS) standards is pivotal for organizations worldwide. However, establishing and maintaining this framework demands time and effort. This is where Wismatix steps in to alleviate your concerns.

Are you seeking ways to measure customer satisfaction and streamline document and record management? With Wismatix, you can relinquish your worries. Simply reach out to us at sales@wismatix.eu, and we’ll guide you on the path to success.

Comprehensive Services for the Technology Industry

Our consulting services encompass a wide array of quality, environmental, IT, and CE standards, tailored specifically to the technology industry:

Quality, Environment, IT and CE Consulting Services within the Technology industry

Excellence in Medical Device Quality Management

Wismatix excels in providing comprehensive consulting services within the medical device sector:

  • ISO 13485:2016
    – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes

  • ISO 14971:2019
    – Medical Devices – Application of Risk Management to Medical Devices

  • ISO 62304:2006/Amd 1:2015
    – Medical Device Software – Software Lifecycle Processes

  • ISO/TR 80002-2:2017
    – Medical Device Software – Part 2: Validation of Software for Regulated Processes

  • FDA Title 21 Part 820
    – Code of Federal Regulations Title 21 – Part 820 Quality System Regulation

  • FDA Title 21 Part 11
    – Code of Federal Regulations Title 21 – Part 11 Electronic Records; Electronic Signatures

  • MDSAP Program / MDSAP Documentation
    – Medical Device Single Audit Program applicable for USA, Canada, Brazil, Australia, and Japan.

Team meeting about Medical device Management Consulting Services

Comprehensive HSEQ/QA Department Outsourcing with Wismatix QMS

When you choose Wismatix QMS as your quality management system, you have the option to enhance your quality, health, safety, environment, and compliance efforts by outsourcing your HSEQ/QA department to us. This add-on service is designed to provide you with a seamless and integrated solution for your organization’s success.

Included Services:

  • Weekly Follow-ups: Our team will conduct regular check-ins with your organization to ensure that quality and compliance measures are being upheld consistently. We’ll address any emerging issues promptly and offer solutions for continuous improvement.
  • Weekly Status Reports to Top Management: Stay informed about the status of your quality and compliance initiatives with concise weekly reports delivered directly to your top management. These reports will provide insights into key metrics, ongoing projects, and any potential areas of concern.
  • Quarterly Audits: We’ll take the lead in planning and executing comprehensive quarterly audits to assess the effectiveness of your quality management systems, safety protocols, and environmental compliance. Our audit team will identify areas for improvement and recommend corrective actions.
  • Quarterly Management Reviews: Our team will collaborate with your management to facilitate and assist in quarterly management reviews. These reviews are crucial for evaluating your organization’s performance, setting objectives, and aligning strategies for continuous growth and compliance.
  • Assisting in Supplier Audits: We’ll partner with your team to plan and conduct supplier audits, ensuring that your suppliers meet your quality and compliance standards. These audits help maintain the integrity of your supply chain and enhance product/service quality.
  • Procedure and Instruction Creation: We’ll assist in developing and refining procedures and instructions within your Quality Management System (QMS) to ensure clarity, consistency, and alignment with industry standards.
  • Ongoing Training in the QMS: Our experts will provide continuous training and support to your team, ensuring that they are well-versed in using the QMS effectively and staying up-to-date with the latest best practices.

Advantages of Outsourcing Your HSEQ/QA Department with Wismatix QMS:

  • Seamless Integration: Enjoy a cohesive solution that integrates your QMS with HSEQ management, promoting efficiency and synergy.
  • Expert Guidance: Benefit from the expertise of our seasoned HSEQ professionals, who are well-versed in industry standards and best practices.
  • Proactive Compliance: Stay ahead of regulatory changes and compliance requirements with our proactive approach.
  • Time and Resource Savings: Save time and resources that would otherwise be spent on hiring, training, and managing an in-house HSEQ department.
  • Continuous Improvement: Leverage our insights to drive continuous improvement across all aspects of your organization.

Outsourcing your HSEQ/QA department with Wismatix QMS not only enhances your quality and compliance efforts but also allows you to focus on your core business activities. It’s a strategic choice for organizations committed to excellence and regulatory compliance.

Contact us today to explore how this add-on service can be tailored to meet your specific needs and take your organization’s quality and compliance to the next level.