MedTech Regulatory Compliance & QMS Experts
Comprehensive support for MDR/IVDR, FDA, and ISO 13485 documentation – scalable, audit-ready and efficient.
MedTech Regulatory Compliance & QMS Experts
Comprehensive support for MDR/IVDR, FDA, and ISO 13485 documentation – scalable, audit-ready and efficient.
Our Services
Find the Right Compliance Path for Your Medical Device
Effectum Medical offers expert-led, audit-proven services that help MedTech teams accelerate time-to-market while ensuring MDR/IVDR, FDA, and AI Act compliance. Choose the service that matches your current challenge or regulatory need.
Outsourced Legal Manufacturer
Launch products under our MDR-certified QMS and reduce your time to market. Includes Notified Body partnerships and fast-track certification.
Plug & Play QMS
Pre-built ISO 13485 / MDR / IVDR / FDA-compliant QMS with SOPs, templates, and on demand cloud-based integration. Ideal for fast execution and internal scaling.
Rent an Expert
On-demand support from Effectum’s senior QA/RA consultants for audits, documentation, QMS setup, or CE marking.
Regulatory Opinions
Get a written expert opinion on classification, applicable standards, and approval roadmap. High value for funding rounds and internal clarity.
Not Sure Which Service to Choose?
Whether you’re building your first device or scaling your operations, we’re ready to help. Book a free 20-minute consultation with one of our regulatory advisors.