Analysis & knowledge

Articles & Whitepapers

In-depth analysis and practical guidance, with references to the regulation instead of buzzwords.

34 entries

ArticleSep 17, 2026

Next Generation Supply Chain: What Holds Up in a Regulated Supply Chain

Visibility, better forecasts, less working capital tied up, a supply that survives the loss of a supplier: the expectations placed on a next generation supply chain are the same in pharma, MedTech and IVD as anywhere else. The route there is not, because every improvement has to land inside the quality system.

ArticleSep 16, 2026

FDA finalizes new 510(k) guidance for dental composite resins and dental curing lights

On 2 September 2026 the FDA issued two final Level 1 guidances for dental composite resins and dental curing lights. They replace the 2005 and 2006 documents and reset what a 510(k) submission is expected to show.

ArticleSep 7, 2026

Japan's 2026 pharmacy exemption for a specified high-control medical device

An MHLW notice adds starch-derived absorbable topical hemostatic material to the list of specified insured materials that a pharmacy may supply without a separate license to sell highly controlled medical devices. The route is conditional, and it changes neither approval nor reimbursement.

ArticleSep 7, 2026

MHRA and Manchester NHS launch a health innovation sandbox: an early signal for AI-enabled devices

The Manchester Sandbox moves the evidence conversation for AI-enabled medical devices into real NHS settings. It is a regulator-enabled evidence environment, not a new authorization pathway, and key operational details have not been published.

ArticleSep 7, 2026

PFAS fluoropolymers in medical devices: what the FDA's 2026 position means for manufacturers

The FDA sees no reason to restrict the continued use of fluoropolymers in medical devices. That statement is narrower than a general declaration that PFAS are safe, and it does not replace device-specific material characterization, biological evaluation or change control.

ArticleSep 7, 2026

The UK Health Bill and a potential Great Britain medical-device licensing regime

Government New Clause 94 would let the Secretary of State create product and personal licenses for defined medical-device activities in Great Britain. It is an enabling power, not an operating regime: nothing in it changes current obligations.

ArticleSep 1, 2026

MDR/IVDR under reconstruction: how Europe is recalibrating its medical device framework

From the accelerated evaluation and COM(2025) 1023 to market feedback, parliamentary work and Council negotiations: how the MDR/IVDR revision is really unfolding, and what it means for ongoing projects.

ArticleAug 25, 2026

From Digital Measurement to Regulatory Evidence

FDA's cross-center paper, published on 20 August 2026, provides a coherent framework for linking digital measurement technologies to regulatory-grade clinical evidence. A virtual public workshop on 27 August will examine the associated statistical and methodological considerations for digitally derived endpoints in clinical trials of drugs and biological products.

ArticleAug 25, 2026

FDA and generative AI: no new policy, but a regulatory framework is taking shape

On 18 August 2026 the FDA published its discussion paper on the regulation of generative AI-enabled medical devices. It is not draft guidance, not final guidance and not a new policy statement. It should not, however, be dismissed as merely exploratory.

ArticleAug 25, 2026

FDA Recognition List 066: managing evidence boundaries, not just updating a standards register

What medical-device manufacturers should do now for biological evaluation, labeling, cybersecurity, and digital health data. Recognition List 066 is easy to misread as routine standards maintenance. It affects the evidentiary architecture behind US premarket submissions.

ArticleAug 25, 2026

UK MedTech: MHRA proposes material changes to medical-device fees from April 2027

The proposed annual post-market surveillance registration fee would rise from £300 to £511, an increase of around 70 per cent. The practical impact depends less on the headline amount than on how an organization's registered portfolio maps across chargeable GMDN categories.

ArticleAug 11, 2026

Hazard and Risk Analysis: Which Method Answers Which Question

PHA, FTA, ETA, FMEA, HAZOP and HACCP each answer a different question, and none of them produces a finished risk analysis on its own. This whitepaper sets out what each method is good for, how to choose between them and what a robust interface to the ISO 14971 risk analysis has to do.

ArticleJul 30, 2026

Quality Agreements With Critical Suppliers

A quality agreement is not an extended purchase order. It is the operating interface between two quality management systems. Which audit, change and cost rules it has to carry so that it gives a clear answer when it matters.

ArticleJul 28, 2026

FDA Inspections Under QMSR: What Program 7382.850 Changes

Since 2 February 2026 the FDA no longer inspects under QSIT but under Compliance Program 7382.850. More consequential than the new procedure, though, is a change in the regulatory text: the protection for management review, internal audits and supplier audit reports is gone.

ArticleJul 24, 2026

QMSR: What Actually Changes for an ISO 13485 QMS

Since 2 February 2026, 21 CFR Part 820 has been the Quality Management System Regulation and incorporates ISO 13485:2016 by reference. A certificate is therefore the foundation, not the conformity: the FDA additions sit in three places, and inspections have followed a different program since the same day.

ArticleJul 23, 2026

PPWR: Why Pharma Packaging Is Not Exempt

"Pharma is exempt from PPWR" is the assumption most likely to fail an audit. The Article 6(11) exemption covers primary packaging, and cartons only where they preserve product quality. The rest is in scope. General application: 12 August 2026.

ArticleJul 16, 2026

Real-World Evidence in Benefit Assessment: Where It Counts

The G-BA and IQWiG do not accept routine-care data as a substitute for randomized trials, yet at one clearly defined point they explicitly require it: the application-accompanying data collection under Section 35a(3b) SGB V. Knowing the difference means planning registries before authorization instead of after the decision.

ArticleJul 14, 2026

The German Reimbursement Amount Is Decided in the Study Design

From the seventh month after market launch, the negotiated reimbursement amount applies. By then the negotiation is no longer about the price but about the consequences of a decision taken long before. And what limits the headroom changed on 30 July 2026: the guardrails in Section 130b(3) SGB V have been restructured and the combination discount is gone.

ArticleJul 7, 2026

JCA and AMNOG: The EU Assessment Does Not Replace the German One

Joint clinical assessments have applied to oncology medicines and ATMPs since 12 January 2025. They do not replace the German benefit assessment under Section 35a SGB V. Added benefit, the appropriate comparator therapy and the price stay national. What changes is timing: the EU dossier falls due before marketing authorisation is granted.

ArticleJun 18, 2026

Computer System Validation: Two New Standards, One 12-Week Window

The revised Annex 11 is in final consultation. Annex 22 sits alongside it in draft: the EU's first dedicated guidance on AI in GMP manufacturing. Read them side by side and the message is the same. The bar for trusting a computerised system is moving up.

ArticleJun 10, 2026

MDR Meets the EU AI Act: The Trilemma for AI Software

AI software that qualifies as a medical device must satisfy the MDR and the EU AI Act at the same time. The costly mistake is not the second regulation, but running two separate worlds of documentation. Where MDR classification and AI Act high-risk status interlock.

ArticleJun 2, 2026

What manual visual inspection really costs

We fully costed a completed AVI project: 89 inspectors replaced by two automated systems, 4.2 million euro in annual savings, ROI in under 2 years.

ArticleJun 2, 2026

The EU AI Act for Life Sciences: When AI Counts as High-Risk

Whether AI in a medical device or IVD counts as high-risk AI is decided not by the technology but by the conformity assessment route under the MDR or IVDR. How Art. 6 of the EU AI Act triggers the classification and which application dates matter.

ArticleMay 28, 2026

CDMOs as Strategic Partners: From Capacity Provider to Co-Creator of Value

The pandemic has recalibrated the role of CDMOs. A CDMO that only sells capacity stays interchangeable; one that brings together digitalization, joint planning and resilience becomes a strategic partner. The four building blocks of this transformation and what they mean for partner selection.

ArticleMay 20, 2026

FMEA or FTA? Why Choosing the Method Will Not Save Your Risk Analysis

In many MedTech projects, the first question is which method to use for the risk analysis. That question falls short: quality is not determined by the method, but by the fit between the question, the method, and integration into the logic of ISO 14971.

ArticleMay 14, 2026

Regulatory Intelligence: Not the Best Tool, but the Right Fit

When selecting a regulatory intelligence solution, success depends on the fit with your own regulatory context. Why feature lists are misleading and which four dimensions actually decide the outcome.

ArticleMay 12, 2026

From Regulatory Text to Requirement: How Annex 11 Becomes Testable Audit Trail Specifications

What an audit trail must deliver is set out in Annex 11, 21 CFR Part 11 and the data integrity guidelines. What this means for a specific system is not. How a single regulatory paragraph can be translated into testable user requirements using qualitative content analysis.

ArticleMay 6, 2026

CSV Does Not End at Qualification: Periodic Review and Change Control as Common Findings

Many computerised systems are cleanly qualified at go-live and then left to their own devices. That is exactly where the major findings arise: missing periodic reviews and a gap-ridden change control history under EU GMP Annex 11.

ArticleApr 15, 2026

EUDAMED Readiness: Why Registrations Fail in Practice

Since 28 May 2026, the first four EUDAMED modules are mandatory: actors, UDI and devices, notified bodies and certificates, market surveillance. Legacy devices must be registered by 28 November 2026. Four problem clusters we encounter time and again.

ArticleApr 8, 2026

From Lab to Production: The Five Critical Challenges of Biotech Scale-up

Good science is not enough. Anyone seeking to take a biological process from laboratory to industrial scale runs into five challenge clusters that have to be solved simultaneously - technically, commercially and operationally. Where this fails in practice and how the transition succeeds.

ArticleApr 2, 2026

Agile or Waterfall? Why Pharma Projects Must Align the Method With the Question

Whether waterfall or agile is the right approach is not decided in pharma projects by method preference, but by the regulatory character of the undertaking. Where validation-driven projects need structure, where digitalization benefits from iteration, and why the hybrid approach usually wins.

ArticleMar 26, 2026

Leadership Gap 2035: The Quiet Turning Point in Pharma Leadership

Less visible than AI or new therapies, but strategically just as consequential: by 2035 a large part of today's generation of leaders will leave the pharmaceutical industry. Where the gap arises and the six fields of action with which companies can close it.

ArticleMar 18, 2026

Effective GxP Audit Preparation: Weak Points, Mock Audits, CAPA Maturity

Most audit findings do not arise from the fine detail of a single regulation but from recurring structural gaps: superficial root-cause analysis, unverified data integrity, a supplier program that is not risk-based. Recognizing these patterns before the inspection lets you close the gap while there is still time to do so.

ArticleMar 15, 2026

AI in Medical Technology: The Interplay of AI Act, MDR and IVDR

When does AI software qualify as a medical device? What requirements does the AI Act place on high-risk systems? And what do the current deadlines mean concretely for manufacturers? This whitepaper structures the regulatory complexity and translates it into options for action.

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