Regulatory

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.

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.

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.

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.

Guide to FDA export certificates for medical devices, including CFG, CFS, COE, CECATS applications, fees, eligibility, common mistakes, and global market access steps.

Build FDA-ready Predetermined Change Control Plans for AI/ML devices, including PCCP components, submission strategy, examples, and implementation steps.

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.

Guide to LDT regulation after FDA's 2024 rule was vacated, covering CLIA oversight, enforcement discretion, ACLA litigation, and steps laboratories should take.

Medical device SBOM guide covering FDA cyber device requirements, NTIA minimum elements, SPDX and CycloneDX formats, VEX integration, tooling, and postmarket management.

FDA 21 CFR Part 11 guide for medical device electronic records, e-signatures, audit trails, system validation, CSA expectations, ISO 13485, and QMSR alignment.

Guide to document control for medical device companies, covering ISO 13485 clause 4.2, FDA 21 CFR 820.40, eQMS use, change control, version control, and audit findings.

Regulatory guide to 3D printed medical devices, covering FDA pathways, EU MDR classification, patient-matched devices, point-of-care printing, process validation, and key standards.

Use FDA recognized consensus standards in 510(k), De Novo, and PMA submissions — Declaration of Conformity, key standards, and common mistakes to avoid.

Guide to FDA and EU MDR rules for single-use device reprocessing, covering 510(k)/PMA needs, Article 17, Common Specifications, cost savings, and 2026 EU changes.

Plan ISO 13485 certification budgets with 2026 cost ranges, auditor expectations, certification body selection tips, ISO 9001 differences, and FDA QMSR context.

Everything you need to prepare for an MDSAP audit — the 2026 updated audit approach (AU P0002.010), QMSR alignment, step-by-step preparation checklist, costs, timelines, and common nonconformities.

Compare medical device registration costs, government fees, project budgets, and timelines across the US, EU, Brazil, Japan, Korea, India, China, Saudi Arabia, UK, and more.

MENA medical device labeling guide covering Arabic language rules, UDI requirements, halal certification, and country expectations for Saudi Arabia, UAE, Egypt, Israel, Turkey, and Qatar.

Original analysis of 111,000+ ANVISA medical device registrations, showing Brazil market trends, leading registration holders, category shifts, and market entry strategy.

Guide to digital health and AI medical device regulation in MENA, covering Saudi SFDA, UAE EDE, Turkey TITCK, Israel AMAR, SaMD, mHealth, DTx, and compliance strategy.