seca earns certification according to ISO 9001, ISO 13485 and the Medical Device Single Audit Program (MDSAP)

Quality management satisfies global requirements and secures seca competitive advantages

- The German and French quality management systems of seca, the leading manufacturer of medical measuring systems and scales, have been certified according to the revised standards ISO 9001 and ISO 13485 in an audit conducted by TÜV-Süd. In addition, the quality management system at seca headquarters in Hamburg received the Medical Device Single Audit Program (MDSAP) certificate. It shows that seca officially satisfies not only the legal requirements in Europe, but also in the USA, Canada, Australia, Japan and Brazil.

International law makers and government agencies joined up in MDSAP in order to reduce the number of QM system audits in the different target markets. "MDSAP certification allows us to minimize the redundant efforts involved with fulfilling country-specific quality requirements as the participating national registration agencies accept the MDSAP audit report in place of their individual inspections. In future we will be able to accelerate the process of gaining market approvals," said  Mark Sonnenkalb, Head of Quality Services at seca. "Meeting the toughest quality standards is part of the seca DNA. The certificates are now the official proof that our products fulfill the requirements of the MDD  in Europe and of the five countries participating in MDSAP. Beyond that, the certification secures market access in those countries now and in future."

The seca portfolio includes classic medical measuring systems and scales along with innovative solutions such as networked vital signs monitors, measuring stations that communicate with each other, service and software systems that simplify everyday medical work and the medical Body Composition Analyzer (mBCA), which has the potential to revolutionize diagnostics and treatment with the use of Bioelectrical Impedance Analysis. seca medical products in Classes I, Im and IIa must fulfill  strict quality requirements. The recently conducted audit has confirmed that they do.

1Medical Devices Directive

You'll find more information about seca at www.seca.com.

Press Contactseca gmbh & co. kg
Anika Otto; Communications Manager
e-mail: anika.otto@seca.com
Tel.: +49 40 20 00 00 411
www.seca.com

seca – precision for healthSince 1840 seca has perfected the skill of developing innovative weighing technology combined with practical functions and has become the world's market leader in medical measuring and weighing. seca measuring systems and scales are sold by 14 branch offices and exported to 110 countries. The seca service network guarantees continuous maintenance of the precision instruments. To provide doctors and medical personnel with professional support, seca maintains close contact to users and tailors innovative products to the exact  needs of their medical applications. Examples include networked measuring stations that communicate with each other, service and software systems that simplify medical routines and the medical Body Composition Analyzer (mBCA) which uses Bioelectrical Impedance Measurement (BIA) to revolutionize diagnostics and treatment. Ultra-modern production technology, durable materials and a worldwide quality management system ensure top-level product standards.

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