Get Audit-Ready with a Pre-Built, on-demand Cloud-based (e)QMS
Effectum’s Plug & Play QMS delivers an ISO 13485 / MDR / IVDR / FDA-compliant system with ready-to-use SOPs, templates, and software integration. It enables easy customization for the optimal fit to your company needs.
Get Audit-Ready with a Pre-Built, on-demand Cloud-based (e)QMS
Effectum’s Plug & Play QMS delivers an ISO 13485 / MDR / IVDR / FDA-compliant system with ready-to-use SOPs, templates, and software integration. It enables easy customization for the optimal fit to your company needs.
Plug & Play QMS
We provide a complete Quality Management System — instantly deployable and aligned with regulatory frameworks in the EU, US, Japan, and Australia. Choose between Qualio-based eQMS or SharePoint access. It enables easy customization for the optimal fit to your company needs. We can also assist you during your customization and even for the training and management of your own QMS.
Key Services
- Compliant: ISO 13485, MDR, IVDR, FDA, Japanese & Australian standards
- Audit-proven: Passed 15+ inspections
- Configurable: Use in Qualio or document-based. Also implementable in any other eQMS software tool.
- Efficient: Saves time and avoids setup delays
- Exclusive Qualio pricing: Via Effectum’s Qualio partnership
When to Choose This Service On-demand customization
- On-demand training
- QMS Management (incl. audits etc…)
- Documentation reviews
- PRRC / QMR services
Team QMS | Camilla Messerli
Head of Quality Management & Regulatory Affairs
Accelerate your QMS setup and launch timeline.
Book a demo or consultation today.
What Clients Say
Dr. Anjali Raja Beharelle, Co-Founder at Collabree
The ready-to-use documentation provided a solid foundation, which significantly accelerated our setup. It’s comprehensive and saves a lot of time.
Gregegorz Wielgoszewski, Senior R&D Engineer, Resistell
We benefited from all the experience that Effectum Medical had in complying with standards and other regulations, starting from ...
Dr. Anjali Raja Beharelle, Co-Founder at Collabree
The ready-to-use documentation provided a solid foundation, which significantly accelerated our setup. It’s comprehensive and saves a lot of time.