Family of home medical monitoring devices

Certificaciones y cumplimiento normativo

Certificaciones regulatorias y de calidad en los principales mercados, para que una sola fuente de producción sirva a varias regiones.

Certifications held

FDA US market Cleared device listings; zero FDA observations since 2018, FDA fly check April 2024
CE / EU MDR European Union MDR-compliant CE marking (NB 0123 / 0598)
NMPA China market Registered devices; NMPA fly check
ISO 13485 Quality management Medical device QMS
ISO 14001 Environmental management Environmental QMS
ISO 45001 Occupational health & safety OH&S management
MDSAP Medical Device Single Audit Program Covers US, Canada, Brazil, Japan, Australia
Health Canada (MDL) Canada market Medical device licences
PMDA Japan market Registration pathway
TGA Australia market ARTG entry via MDSAP
UKCA United Kingdom UK conformity assessment
INMETRO / ANVISA Brazil market Product certification & registration
BSCI Social compliance Audited supply chain
SMETA Social compliance Sedex members ethical audit
CA65 California Prop 65 Chemical exposure compliance
RoHS Hazardous substances Restriction compliance
REACH Chemical safety EU chemical regulation
RED Radio equipment EU Radio Equipment Directive
FCC Radio frequency US RF compliance
Bluetooth SIG Connectivity Bluetooth SIG member
CFS Free sale certificate Export documentation

Certification	Applies to	What it means for you
FDA	US market	Cleared device listings; zero FDA observations since 2018, FDA fly check April 2024
CE / EU MDR	European Union	MDR-compliant CE marking (NB 0123 / 0598)
NMPA	China market	Registered devices; NMPA fly check
ISO 13485	Quality management	Medical device QMS
ISO 14001	Environmental management	Environmental QMS
ISO 45001	Occupational health & safety	OH&S management
MDSAP	Medical Device Single Audit Program	Covers US, Canada, Brazil, Japan, Australia
Health Canada (MDL)	Canada market	Medical device licences
PMDA	Japan market	Registration pathway
TGA	Australia market	ARTG entry via MDSAP
UKCA	United Kingdom	UK conformity assessment
INMETRO / ANVISA	Brazil market	Product certification & registration
BSCI	Social compliance	Audited supply chain
SMETA	Social compliance	Sedex members ethical audit
CA65	California Prop 65	Chemical exposure compliance
RoHS	Hazardous substances	Restriction compliance
REACH	Chemical safety	EU chemical regulation
RED	Radio equipment	EU Radio Equipment Directive
FCC	Radio frequency	US RF compliance
Bluetooth SIG	Connectivity	Bluetooth SIG member
CFS	Free sale certificate	Export documentation

ISO 13485 quality management

Our quality system follows ISO 13485. In practice that governs design control, supplier qualification, production traceability, non-conforming material handling and post-market surveillance — the records a notified body or a large retail customer will audit.

Design awards

Our products have won 8 international design awards, including the Red Dot Product Design Award (2019 & 2023) and the iF Product Design Award (2019, 2021, 2022 & 2023). These are design awards for the industrial design work, not regulatory approvals — we list them separately on purpose.

What we can hand over

Certificate copies and scope statements.
Test reports from accredited laboratories.
Declarations of conformity and, where applicable, FDA clearance numbers.
Technical file extracts for your own regulatory submission.

Which certifications apply to a specific model?

Certification scope is model-specific. The section-level list describes the manufacturer’s systems; ask us for the certificate set for the exact model you intend to buy and we will send it.

Do you hold EU MDR CE?

Yes. Our EU MDR CE certification covers our home vital-sign device lines.