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Gowned technicians assembling and inspecting medical devices in a clean, modern Costa Rica manufacturing lab.

MedTech News

Discover curated MedTech news, conferences, workshops, and regulatory trainings relevant to Costa Rica’s growing ecosystem.

Managing Change in Regulated MedTech Software

🧭 TL;DR Who this article is for This article is for MedTech project managers, product managers, software leads, QA/RA, systems engineers, cybersecurity leads, and supplier-quality partners working with regulated software, SaMD and SiMD, connected devices, or hybrid medical-device programs. It is especially useful for teams trying to reconcile two pressures that often feel opposed: How…

Stakeholder Management in MedTech

Stakeholder management in MedTech is not a “soft skill.” It is part of the design-control and risk-control system that determines whether a product can be safely released, adopted, supported, and defended with objective evidence. This article is MedTech-first and experience-based. In regulated medical software, stakeholder management is not just communication. It is how expectations become…

Unpacking the Project Performance Domains

Project performance domains are one of those concepts that sit quietly underneath everything in modern project management: they’re not a “method,” but they often determine whether the work is coherent, repeatable, and value-realizing. I’m writing this from the perspective of a program manager in high‑stakes engineering (MedTech and other regulated environments). I started learning with…

Vacuum Science

Vacuum is a process condition created by a system (surfaces + geometry + pumps + plumbing + gauges + sequencing) that you tune to get repeatable film chemistry, plasma behavior, transport, and cleanliness. There is no single spec or a single pump that can get you there. Vacuum in clean manufacturing is mainly about contamination…