Approvals with
Regulatory approvals for medical devices with ANMAT, ANVISA, FDA and CE, coordinated in a single strategy
Over 27 years and 190 approvals helping medical device manufacturers and biotech companies reach the market faster and with less rework. We design one regulatory strategy that serves several jurisdictions at once.
The cost of a poorly designed regulatory process
In medtech and biotech, time is literally money: every month a product waits for approval is a month of sales that do not happen and capital that stays locked. And most delays do not come from the authority, but from how the process was designed.
- A wrong risk classification sends the product down the wrong regulatory route and costs months.
- Dossiers built country by country, with no common design, force you to redo documentation over and over.
- Every poorly answered information request restarts the authority’s clock.
- Without a sequencing strategy, you lose the chance for one approval to enable or accelerate the next.
None of this is inevitable. With a strategy designed well from the start, the path to market is shorter, more predictable and far less expensive.
From business case to a QMS in production
We cover the full product life cycle, with one head across all three stages: decide, comply and operate.
Feasibility assessment and launch strategy
Before you invest: is it worth launching? With which formulation? In which market order? Integrated financial, quality and market simulation.
View service ComplyMedical device registration and approval
Strategy and management of your device registration with ANMAT, ANVISA, FDA and CE, coordinated in a single base dossier.
View service ComplyISO 13485 Quality Management System
Implementation of your audit-ready QMS, aligned with the FDA QMSR now in force.
View service ComplyISO 14971 risk management
The risk management file your dossier requires in any jurisdiction.
View service ComplyRegulatory affairs and ongoing compliance
Renewals, change management and post-market surveillance to keep your product current.
View service OperateDocQMS Regulado (platform)
The document QMS that sustains your operation once on the market: document control, e-signature, CAPA and a traceable audit trail.
View platformA strategy that moves forward in several markets at once
- Simultaneous multi-jurisdiction coordination.We do not work one country at a time: we design a strategy that advances with ANMAT, ANVISA, FDA and CE in parallel.
- One base dossier, several markets.Documentation is designed to be reused across jurisdictions and avoid rework.
- Senior judgment from the first meeting.Over 27 years and 190 approvals: you do not pay for anyone’s learning curve.
- Focus on time-to-market.Every decision is weighed by its impact on when you will be able to sell.
Four stages, one consistent approach
Diagnosis and strategy
We analyze the product, its classification in each market, and define the optimal route and sequence.
Multi-jurisdiction dossier design
We build a coherent documentation base designed to serve several authorities.
Submission and management
We submit to the authorities and answer their queries until approval is granted.
Maintenance and surveillance
We keep the registration current: renewals, changes and post-market surveillance.
Experience that translates into predictability
Over 190 regulatory approvals obtained in four key jurisdictions over 27 years. In practice, that track record is a library of criteria on what each authority expects and how to avoid the mistakes that cost months.
Meet Matías WarscherReady to shorten your path to market?
Tell us which product you want to register or which quality system you need to implement. The first conversation is about understanding your case, free of charge.