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LCAS™ Calculators
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MDR (EU) 2017/745
Medical Devices — Class I
MDR (EU) 2017/745 — class I (Im/Is/Ir with NB)
R&D / Validation
from €420
Lab minimum may apply ~€1000
BC×CF(1.0) · O=15%
- Technical report
- No accreditation required
- R&D / internal validation
Most popular
Accredited
from €680
Lab minimum may apply ~€1000
BC×CF(1.1) · O=30% · ISO 17025
- ISO 17025 accredited report
- Accepted by EU authorities
- CE certification
NB Certification
from €1800
Lab tests + min. NB fee
- Notified body involvement
- Full certification
- Required for certain product classes
Typical lead time: 10–20 weeks
LCAS™ 1:2025 reference price. Indicative estimate ±40%. Not a commercial offer. Contact the laboratory directly for a binding quote.
How is it calculated? — BC Breakdown
L — Labour (6h × €50)
€300
M — Materials
€30
E — Equipment (3h × €50)
€150
O — Overhead (per tier)
—
L+M+E Subtotal
€480
Overhead O (per tier)
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BC × CF = Price
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Starting prices (EUR 2025, PL/EU market). Complex projects → Single Test calculator with higher CF. Calibration source: MedEnvoy €5k–€15k full procedure (here: lab scope).