Sherif Elkhadem
Articles by Sherif Elkhadem
MHRA's Carbon Inhaler and Philips' Skin-Tone Oximeter Signal a Shift
Two approvals this week—MHRA's low-carbon inhaler and FDA clearance for Philips' equity-focused oximeter—reveal regulators rewarding innovation that serves public health *and* planetary outcomes.
22 July 2026Cosmetics Innovation Awards Signal Functional Ingredient Shift
CPL Aromas' alcohol-free fragrance tech win reveals sustainability and safety converging—driving reformulation waves that cross cosmetics and medical device boundaries.
Surgical robot CE marks and AI supply compliance: two sides of one strategic question
Medicaroid's Hinotori CE Mark and Renfro's AI compliance tools both signal the same shift: complexity at scale demands evidence architecture, not documentation sprints.
17 July 2026SaMD Evidence Architecture: Why GitHub Isn't Your Problem
As Greenlight Guru warns that most SaMD compliance failures stem from fragmented evidence, not missing documentation, two new CE/UKCA launches reveal what audit-ready actually looks like.
Medicaroid's CE Mark: What Surgical Robot Approval Reveals Now
Medicaroid's Hinotori robot just cleared CE Mark for Europe—signaling clinical evaluation expectations for high-complexity devices have shifted. Here's what your MDR strategy needs.
13 July 2026MHRA Enforcement Intensifies: What 15 Years of Jail Time Means
Four individuals just received nearly 15 years combined jail time for illegal online medicine supply. For medical device and IVD manufacturers, this MHRA enforcement milestone signals a regulatory environment that's moved decisively past warnings.
10 July 2026Post-Market Surveillance: From Compliance Ritual to Clinical Loop
ISO 14155:2026 arrives with no transition period, while most PMS systems still can't translate complaints into clinical action. Here's what audit-ready really means now.
8 July 2026FDA's Peptide Review Signals New Era for Cosmetics–Device Boundaries
The FDA's July peptide review isn't just about cosmetics—it's redefining the regulatory line between cosmetic claims and device classification. Here's what MedTech and cosmetics teams need to know now.
6 July 2026New MDR/IVDR Standards Published + Greenlight Guru's ISO 42001
The EU just published fresh harmonised standards for MDR and IVDR—while Greenlight Guru became the first eQMS vendor with ISO 42001 AI certification. Here's what both mean for your compliance stack.
3 July 2026BrightHeart's CE Mark and Edwards' LAA Clip: What AI and Competitive Approvals Mean for Your Regulatory Strategy
BrightHeart's prenatal AI platform just secured CE Mark under IVDR, while Edwards' LAA clip approval sets up a three-way FDA battle. Both signal regulatory expectations shifting fast.
FDA Breakthrough Device Designation for AI Heart Failure Monitor
Heartfelt Technologies' FDA breakthrough designation for AI-powered home heart failure monitoring reveals what regulators are prioritising—and what RA teams need in their evidence packages now.
AI Diagnostics Clear IVDR: What Two CE Marks Tell Us About SaMD
Spotlight Medical and BrightHeart just secured IVDR CE marks for AI diagnostics. For SaMD teams, these approvals reveal a unified pathway—and new expectations.
BrightHeart's CE Mark and the FDA–MHRA AI Partnership: Converging Signals for SaMD Teams
BrightHeart's prenatal AI platform just cleared CE Mark, while FDA and MHRA deepen their liaison on software devices. For RA teams, these aren't separate stories—they're a unified message.
AI-First Supply Chains and Post-Market Loops: The RegTech Agenda
AI is no longer optional for MedTech supply chains or QMS workflows. New insights show how AI-driven adaptability and post-market design loops separate reactive teams from those scaling compliance.
FDA Warning Letter, Supply Shocks: Why Quality Can't Wait
Zoll's FDA warning letter and Hologic's breast biopsy needle shortage reveal a common thread: quality gaps ripple across the entire MedTech ecosystem.
FDA–MHRA Liaison and SaMD Evidence: What Just Changed
A new FDA–MHRA liaison programme and renewed focus on continuous clinical evidence signal a fundamental shift in how software devices will be regulated across borders.
Audit Readiness as Product Strategy: Why Compliance Can't Wait
As FDA shifts toward continuous oversight and one-day inspections, manufacturers clinging to 'pre-audit scrambles' risk more than citations—they're losing speed to market.
MHRA's AI Push: What SaMD Developers Must Know About Risk Management
The MHRA is accelerating AI in healthcare with new sandboxes and public insight. For software medical device teams, this means ISO 14971 just became mission-critical.
12 June 2026Clinical Evidence Under EU MDR: What Robotic Surgery Reveals
Medtronic's Hugo platform demonstrates how device complexity intersects with clinical evaluation rigour. Here's what your EU MDR strategy needs now.
10 June 2026Clinical Evaluation Under EU MDR: Why It's Not Just Documentation
Clinical evaluation has shifted from box-ticking to the cornerstone of EU MDR compliance. Here's what rigorous post-market vigilance teaches us.
8 June 2026EUDAMED Goes Live: What Mandatory Use Means for Your MDR Strategy
From 28 May 2026, EUDAMED's first four modules became mandatory. Combined with MDR revision talks, the regulatory landscape just shifted—here's what changes.
5 June 2026AI-Driven Risk Prediction in Paediatrics: What RA Teams Must Know
A new AI tool estimating childhood ADHD risk highlights the regulatory complexity of predictive diagnostics. Here's what device manufacturers need to consider now.
3 June 2026Why Explainability Is Now a Market Access Requirement for AI/ML
FDA's shifting stance on algorithmic transparency and a major recall underscore a new reality: if your AI medical device can't explain itself, it won't clear regulatory hurdles—or survive post-market.
1 June 2026SaMD Production Controls and the Real Cost of Post-Market Failures
As ISO 13485 guidance clarifies software production controls, Insulet's 7M device recall shows why rigorous QMS discipline matters—even for established players.
29 May 2026