Calculators, references, components
Open to all

Our mission

Before any quote, before any contract, we want to be useful to the medtech community. Every tool here came out of a real need: an ASTM F1980 calculation to run during a meeting, an ISO 10993 matrix to put together for a design file, a French ↔ inch ↔ gauge conversion to check before a customer call.

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We built them for our own team, and we're opening them up to the rest of the community. Advancing healthcare innovation doesn't start with signing a contract. It starts with breaking down the technical and regulatory walls every medtech engineer runs into, every day.

5 quality & regulatory tools

Calculators and references for design, V&V, and standards compliance. ASTM, ISO, ANSI/ASQ. For use across the full development cycle, from early scoping to the technical file.

ISO 16269-6 calculator
V&V sample size

Sample size determination for statistical tolerance intervals. Parametric (normal distribution) and non-parametric methods. Enter the covered proportion (P) and the confidence level (1 − α). Returns the minimum n and the associated k-factor.

Tags · ISO 16269-6:2014 · k-factor · Parametric / non-param. · P / (1−α)

ASTM F1980 calculator
Accelerated aging

ISO 10993 test selector Biocompatibility

Biocompatibility test matrix per ISO 10993-1:2018. Selection by contact category (surface, external communicating, implant) and exposure duration (A: ≤ 24 h; B: 24 h – 30 d; C: > 30 d). Returns the list of tests to run with the associated documentation.

Tags · ISO 10993-1:2018 · Categories A / B / C · Contact matrix · 12 tests

Accelerated aging duration for sterile barriers per ASTM F1980-21. Enter target shelf life, accelerated temperature, and reference temperature. Adjustable Q₁₀ coefficient. Returns the equivalent oven time with Arrhenius plot and ISO 11607-1 alignment.

Tags · ASTM F1980-21 · Q₁₀ Arrhenius · ISO 11607-1 · SVG plot

AQL ISO 2859-1 calculator
Lot-by-lot inspection

Single sampling plans per ANSI/ASQ Z1.4-2003 (R2018) and ISO 2859-1. Select lot size, inspection level (S-1 to S-4, I to III), AQL, and plan type (normal, tightened, reduced). Returns sample size n and Ac/Re thresholds.

Tags · ANSI/ASQ Z1.4 · ISO 2859-1 · Normal / tightened / reduced · S-1 to III

Sterilization compatibility matrix materials

Materials × sterilization methods compatibility table: ethylene oxide (EtO), gamma (25–50 kGy), steam (121–134 °C), e-beam, H₂O₂ plasma. Medical polymers (Pebax, PVC, PE, PP, PEEK, silicone), metals, and adhesives.

Tags · 5 methods · 25+ materials · Polymers / metals · Combined filters

The first European platform to prototype your delivery system

Alongside the calculators, we've built Protobrix: a European platform where you order the components you need to assemble your prototype. Shipped from Europe in under 7 days.

Available today:

• Universal U-handle: our dual-control handle, unique on the market. Steer a shaft with two independent controls (bidirectional steering + rotation, or two pull-wires).

• Nose cones: ready-to-use atraumatic tips, with an overmolding option on existing shafts.