Elevate Your Compliance Management with Wismatix QMS!
Wismatix QMS – Your Comprehensive Solution for Tech Industry Compliance
In the dynamic world of tech development and manufacturing, where precision and compliance are paramount, meet your all-encompassing software companion: Wismatix QMS.
Tailored for companies engaged in machine automation, renewable energy, medical devices, defense, avionics, offshore, and the maritime industry, our suite is designed to handle the full spectrum of non-financial tasks. While quality management remains at the core, our solution serves as an umbrella, seamlessly integrating environmental management, product compliance, and more.
With Wismatix QMS, you gain the power to navigate the intricate web of ISO management standards, quality regulations, and product compliance requirements. Streamline your operations, ensure precision, and stay ahead of the curve in your industry. Welcome to a new era of compliance and efficiency in the tech world.
We specialize in compliance services for companies within these industries
FDA and ISO links
FDA (Food and Drug Administration) – eCFR (Electronic Code of Federal Regulations)
- CFR Title 21 Part 11 – ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
- CFR Title 21 Part 820 – QUALITY SYSTEM REGULATION
ISO (International Organization for Standardization)
- ISO 9000 family – Quality management
- 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 / IEC 62304:2006 / Medical device software — Software life cycle processes