Practical guides for diagnostics, genomics and medical device companies, written from hands-on experience building quality systems and bringing regulated products to market.
ISO 13485
The international standard for medical device quality management systems: what it requires, how to build a lean system that works, and how to get certified. Eight in-depth sections cover design controls, risk management, CAPA, suppliers, software and AI, certification and the FDA QMSR.
IVDR
The EU In Vitro Diagnostic Regulation explained: scope, classification, conformity assessment, performance evaluation, technical documentation, post-market surveillance, EUDAMED and the transition deadlines, plus what the proposed reform could change.
Need help? Salto Partners guides diagnostics, genomics and medical device companies through ISO 13485 and IVDR. Send us an email and we will set up a conversation.
For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.
Perspectives
Andreas Scherer’s view on where genomics and precision medicine are heading, and what it means for the leaders building the business.
National Genome Programs Are Infrastructure, Not Research
Why national genome programs turn precision medicine into standard care, and what that means for health systems, vendors and investors.
Pharmacogenomics: From a Single Test to Shared Infrastructure
Test once, reuse for life: how PGx becomes health-system infrastructure.
Long-Read Sequencing: Plan for Hybrid, Not Replacement
Where long reads close the blind spots of short-read workflows, and how labs should prepare.
AI in Clinical Genomics: The Real Question Is Accountability
Why grounding, auditability and human ownership decide which AI belongs in a regulated lab.