Insights

Practical guidance on quality, risk & data

Working notes from the field — what the standards actually require, where programs get stuck, and how to build evidence that holds up under audit. Written for quality, regulatory, and R&D teams in medtech and combination products.

QMSR & ISO 13485 ISO 14971 Statistics 21 CFR Part 4 Design Controls

Latest · Quality Systems

CAPA Effectiveness Checks That Actually Close the Loop

"Retrained the operator. Training records on file. CAPA closed." Nothing in that record is false — it just never establishes whether the problem stopped. What separates a completion check from a real effectiveness check, and how long you actually have to watch.

5 Sep 202610 min read

Read the article

Statistics

Process Capability (Cpk and Ppk): What Auditors Actually Expect

A capability index compresses an entire process into a single verdict. What the indices actually measure, the three prerequisites nobody documents, and why an observed Cpk of 1.33 is weaker evidence than it looks.

7 Aug 202610 min read

Quality Systems

The QMSR Transition: What Actually Changes in Your Quality System

The FDA's Quality Management System Regulation incorporates ISO 13485:2016 into 21 CFR Part 820. What genuinely changes, what stays, the FDA-specific requirements that remain, and a practical transition sequence.

15 Jun 20269 min read

Statistics

Sample Size Justification for Design Verification

"We used n=30 because we always use 30" is not a justification. A practical framework for choosing and defending sample sizes using confidence/reliability, the success-run theorem, and tolerance intervals.

20 May 202610 min read

Combination Products

21 CFR Part 4: One Quality System for a Combination Product

The streamlined approach lets you run a single quality system instead of two. What it actually requires, how to choose your base system, and the integration gaps that surface in audits.

28 Apr 20269 min read

Risk Management

What Auditors Look For in an ISO 14971 Risk Management File

Most risk files fail on the same four things: broken traceability, control options applied out of order, a thin overall residual risk conclusion, and no production feedback loop. Here is how each gets found.

17 Mar 20268 min read

New articles are published periodically. Have a topic you would like covered, or a question about your own program? Get in touch.

Insights by email

Practical guidance on quality systems, risk management, and statistics for combination products and medical devices — sent when a new article goes up. Roughly one email a month. No sales pitches, and you can unsubscribe from any of them.

First name

Last name optional

Email address

Company optional

We will send a confirmation email — click the link in it to complete your subscription. We use your details only to send these articles, never sell them, and you can unsubscribe at any time. See our Privacy Policy.

This form needs JavaScript. Email info@dpdynamicsol.com and we will add you to the list.

Let's talk

Have a question these articles don't answer?

Bring us the specifics of your product and program. A 30-minute call is usually enough to point you at the right first step.

Book a consultation Explore services

No obligation · Direct with a principal consultant