Your legal manufacturer for Software as a Medical Device.
We act as the legal manufacturer under EU MDR for your SaMD — placing your software on the European market under our certification and responsibility, so your team doesn't have to build a full regulatory and quality structure.
Legal and contract manufacturing for your software medical device.
From classification to CE marking and post-market obligations, we take on the manufacturer's regulatory responsibilities so you can focus on the product.
Legal Manufacturer (MDR Art. 10)
We take on the legal manufacturer role for your SaMD: placing the device on the EU market under our brand, certification, and regulatory responsibility.
ISO 13485 Quality Management System
We operate the quality management system the device requires, integrating your software development processes.
Technical Documentation & CE Marking
Preparation of the MDR technical file and coordination of the conformity assessment with the notified body through to CE marking.
Classification & Regulatory Strategy
Defining the intended use, classifying the SaMD (Rule 11), and selecting the most appropriate regulatory pathway.
Software Lifecycle (IEC 62304)
Software lifecycle processes, risk management (ISO 14971), and usability engineering (IEC 62366) applied to your product.
Vigilance & Post-Market
Post-market surveillance, post-market clinical follow-up (PMCF), safety reporting, UDI, and EUDAMED registration.
Specialised, hands-on, and focused on medical software.
Placing a software medical device on the European market requires a legal manufacturer with a quality system, technical documentation, and ongoing regulatory responsibility — an expensive, slow structure to build from scratch.
We take on that role for you. Work is handled directly, scoped to your product, and kept aligned with your launch plan — from an initial classification opinion to a full legal manufacturing agreement.
Specialised
Exclusive focus on software as a medical device — not hardware, not generalist consulting.
EU-based
Legal manufacturer established in Portugal, with direct access to the European market.
Shared responsibility
We carry the regulatory burden so your team can focus on building the product.
For teams building clinical software that needs to reach the market.
Digital Health Startups
Teams building clinical applications that need a fast, compliant route to the European market.
AI & Machine Learning
Diagnostic, triage, and decision-support algorithms subject to MDR and AI-specific requirements.
Remote Monitoring & Telehealth
Remote monitoring and remote-care platforms classified as a medical device.
Clinical Decision Support
Clinical decision support systems and regulated digital health software.
Research and innovation with public support.
We take part in co-financed R&D and entrepreneurship projects that strengthen compliance methods and tools for software as a medical device.
MedAIVeritas
AI Validation in Healthcare
A specialized framework for ensuring trust, ethical compliance, and technical validation of Artificial Intelligence systems within the healthcare sector — with a focus on data protection, diagnostic transparency, and DNSH-aligned regulatory practice.
CMP Compliance Labs' role
Part of the consortium, ensuring regulatory compliance and the validation of software as a medical device.
Startup Voucher
Entrepreneurship & Pre-acceleration
Support for developing and validating CMP Compliance Labs' business model as a legal manufacturer of software as a medical device, under the Startup Voucher call.
CMP Compliance Labs' role
Beneficiary of the support.
