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Clinical Evaluation in MedTech – Expert Insights from Sandra Sernbo for Building Safe Medical Device
The article highlights the role of clinical evaluations at GBA Key2Compliance in ensuring that medical devices are safe, effective, and ready for real-world cli...
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We are Strömberg Distribution- Let´s talk 3PL- Medtech-Life Science
We are a trusted 3PL partner with over 40 years of industry experience, delivering specialized expertise in the handling, warehousing, and distribution of Medte...
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Pfeiffer Vacuum+Fab Solutions introducerar COMBI WVD Vakuumboosterpumpsystem
Pfeiffer Vacuum+Fab Solutions – en del av den globala Busch Group – tillkännager lanseringen av vakuumboosterpumpsystemet COMBI WVD. Denna kompakta enhet erbjud...
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Att förstå pumpens sughöjd och dess betydelse
Sughöjd är en viktig faktor för alla som söker en lösning med vätskediaphragmapump. Men vad är sughöjd och varför är det så avgörande?
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Vad utmärker de tillverkare som lyckats med en snabb MDR-certifiering?
Övergången till MDR har generellt inneburit längre handläggningstider i Europa för CE-märkning av medicintekniska produkter. En MDR-certifieringsprocess omfatta...
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Smooth Flow-pumpar – en milstolpe inom innovation inom membranpumpar
Från högupplöst utskrift till livräddande utrustningar levererar vår avancerade flödesteknologi en smidig, pulsationsfri prestanda där precision är allt.
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Internal audits – an opportunity to improve Medical Devices
Internal audits are more than an ISO 13485 requirement — they give medical-device companies a chance to improve product quality and processes. External auditors...
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Shaping regulatory complexity into strategic clarity
As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...
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Au2mate Academy
Au2mate Academy lanseras i Sverige!
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PMS, Vigilance and Risk Management
Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Un...
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IVDR Reality Check: Are We Moving Fast Enough?
As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...
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Could an overly burdensome QMS be the organization’s own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...
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Smooth Flow Pumps – A Milestone in Diaphragm Pump Innovation
From high-resolution printing to life-saving devices, our advanced flow technology delivers smooth, turbulence-free performance where precision is everything.
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New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...
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Membranpumpar – För- och nackdelar
Membranpumpar används i stor utsträckning inom olika industrier tack vare sin tillförlitlighet, mångsidighet och förmåga att hantera gaser och vätskor i medicin...
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Diaphragm Pumps – Pros & Cons
Diaphragm pumps are widely used across industries for their reliability, versatility, and ability to handle gases and liquids in medical, inkjet, analytical, an...
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FDA’s new CSA guidance: transforming software validation for production and quality systems
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.
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Strategic Clarity: The New Currency in Life Science
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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L&B Medical blir återförsäljare av VELA arbetsstolar och ståstödsstolar
L&B Medical AB blir återförsäljare för VELA medicintekniska arbetsstolar och ståstödsstolar. Serien omfattar ergonomiska arbetsstolar för aktivt sittande med en...
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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...
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Ny studie: Tidewave påskyndar sårläkning utan manuell vändning
L&B Medical AB presenterar ny evidens för Tidewave, madrassen som automatiskt repositionerar patienter. I en ny fallstudie från Gent University Hospital läkte e...
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