Regulatory
567 articles
Cloud-Based Medical Devices & SaaS: Regulatory Compliance Guide (FDA, EU MDR 2026)
Guide to FDA and EU MDR regulation of cloud-based medical devices and SaaS health platforms, covering SaMD, SiMD, IEC 62304, cybersecurity, CSA, CRA, and validation.
HIPAA Compliance for Medical Device Companies (2026 Security Rule Update)
Manage HIPAA compliance for connected device companies, including applicability, 2026 Security Rule proposals, encryption, MFA, BAAs, IoMT risks, and FDA cybersecurity overlap.
Mobile Medical Applications: FDA & EU MDR Regulatory Guide (2026)
Classify mobile medical apps under FDA and EU MDR rules, including device software functions, wellness exclusions, CDS updates, Rule 11, cybersecurity, privacy, app stores, and 2026 strategy.
Switzerland Swissmedic Medical Device Registration Guide (2026)
How to register medical devices in Switzerland under Swissmedic: CH-REP duties, MedDO/IvDO rules, swissdamed deadlines, CE reliance, fees, and PMS obligations.
Wearable Medical Devices: Regulatory Pathway Guide (FDA, EU MDR 2026)
Guide to wearable medical device regulation in the US and EU, including FDA wellness policy, 510(k), De Novo, EU MDR classification and manufacturer compliance strategy.
FDA Emergency Use Authorization for Medical Devices: Regulatory Pathway
FDA EUA guide for medical devices covering Section 564 authority, CBRN emergency triggers, submission criteria, EUA vs 510(k)/PMA, termination, and active EUAs.
EU Cyber Resilience Act (CRA) + NIS2: Impact on Medical Device Manufacturers in 2026-2027
Explains how the EU CRA and NIS2 affect medical device companies, including MDR/IVDR exemptions, indirect CRA exposure, supply chain duties, and deadlines.
EU MDR Classification Rules (Annex VIII): Complete Guide to All 22 Rules with 2026 Updates
Walk through all 22 EU MDR Annex VIII classification rules, including invasive, active, software, nanomaterial, and special rules with 2026 guidance.
EU MDR Importer & Distributor Obligations: Complete Guide to Articles 13, 14, and 16
Guide to EU MDR importer and distributor obligations under Articles 13, 14, and 16, including registration, labeling, QMS duties, checks, and MDCG guidance.
EU MDR PRRC Guide: Article 15 Responsibilities and 2026 Changes
Guide to the EU MDR Person Responsible for Regulatory Compliance, covering Article 15 qualifications, duties, outsourcing, MDCG guidance, liability, and 2026 changes.
FDA Medical Device Advertising and Promotion Compliance Guide (2026)
Guide to FDA medical device advertising and promotion compliance, including 21 CFR Part 801, OPEQ enforcement, off-label claims, social media, FTC oversight, and warning letters.
FDA Clinical Decision Support Software: Device vs Non-Device Guide
Guide to FDA clinical decision support software policy, including Section 520(o)(1)(E), non-device CDS criteria, SaMD boundaries, examples, and digital health compliance steps.
FDA Establishment Registration & Device Listing: Complete Compliance Guide
Guide to FDA establishment registration and device listing under 21 CFR Part 807, including FURLS/DRLM, FY 2026 fees, who must register, annual renewal, and common violations.
FDA eSTAR Electronic Submission Template: Complete Guide to 510(k) and De Novo Submissions
Guide to FDA eSTAR electronic submission templates for 510(k) and De Novo, including mandatory use, template structure, completeness checks, submission methods, and common mistakes.
FDA Export Certificates for Medical Devices: CFS, CFG, COE Complete Guide
Guide to FDA export certificates for medical devices, including CFG, CFS, COE, CECATS applications, fees, eligibility, common mistakes, and global market access steps.
FDA PCCP Guide for AI/ML Medical Devices
Build FDA-ready Predetermined Change Control Plans for AI/ML devices, including PCCP components, submission strategy, examples, and implementation steps.
Humanitarian Device Exemption (HDE): Complete Guide to FDA Rare Disease Device Pathway
Use FDA's HDE pathway for rare disease devices, including HUD designation, probable benefit evidence, HDE applications, profit rules, IRB oversight, QMSR, and post-approval duties.
LDT Regulatory Guide: FDA 2024 Rule Vacatur, CLIA Oversight, and Next Steps
Guide to LDT regulation after FDA's 2024 rule was vacated, covering CLIA oversight, enforcement discretion, ACLA litigation, and steps laboratories should take.
SBOM for Medical Devices: FDA Section 524B, EU CRA, and NTIA Guide
Medical device SBOM guide covering FDA cyber device requirements, NTIA minimum elements, SPDX and CycloneDX formats, VEX integration, tooling, and postmarket management.
21 CFR Part 11 Compliance Guide: Electronic Records and Signatures for Medical Devices
FDA 21 CFR Part 11 guide for medical device electronic records, e-signatures, audit trails, system validation, CSA expectations, ISO 13485, and QMSR alignment.