Iso 13485 - Biotechnology

Relevant Publications

Towards IVDR-compliance by implementing quality control steps in a quantitative extracellular vesicle-miRNA liquid biopsy assay for response monitoring in patients with classic Hodgkin lymphoma.

Issue Release: 2024

Diagnostic Performances of an in-House Immunochromatography Test Based on the Monoclonal Antibody 18B7 to Glucuronoxylomannan for Clinical Suspected Cryptococcosis: a Large-Scale Prototype Evaluation in Northern Thailand.

Issue Release: 2024

Medical Devices with Embedded Sensor Systems: Design and Development Methodology for Start-Ups.

Issue Release: 2023

The Biocompatibility of a New Type of 45S5 Bioactive Graft in a Sheep Model: A Pilot Study.

Issue Release: 2023

Apps in healthcare and medical research; European legislation and practical tips every healthcare provider should know.

Issue Release: 2023

Force-adjustable parallel-occlusion grasper.

Issue Release: 2023

Components of Oranta-AO software expert system for innovative application of blood pressure monitors.

Issue Release: 2022

Intraoperative Needle Tip Tracking with an Integrated Fibre-Optic Ultrasound Sensor.

Issue Release: 2022

Moot Court Cases: Bringing Standards to Life.

Issue Release: 2022

DyNeuMo Mk-1: Design and pilot validation of an investigational motion-adaptive neurostimulator with integrated chronotherapy.

Issue Release: 2022

Degradation Phenomena on \"Homemade\" Explanted Aortic Textile Endografts.

Issue Release: 2021

Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485).

Issue Release: 2021

Integrated 3D printing solution to mitigate shortages of airway consumables and personal protective equipment during the COVID-19 pandemic.

Issue Release: 2020

Validation of a novel and accurate ApoE4 assay for automated chemistry analyzers.

Issue Release: 2020

Co-design open-source medical devices: how to minimize the human error using UBORA e-infrastructure

Issue Release: 2019

Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing.

Issue Release: 2019

[From idea to standard care-a field report].

Issue Release: 2018

Technical Note: The design and function of a horizontal patient rotation system for the purposes of fixed-beam cancer radiotherapy.

Issue Release: 2017

Methodology on quantification of sonication duration for safe application of MR guided focused ultrasound for liver tumour ablation.

Issue Release: 2017

[Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

Issue Release: 2016

What Are the Benefits of Precision Medicine?

How Does It Impact Human Health?

What are Quantitative Trait Loci?

What is the Role of Biotechnology in Animal Breeding?

What Are the Benefits of Using Biotechnology for Oil Spill Cleanup?

What are the Benefits?

Why is Biosafety Important?

What is Uranium?

How does Phytodegradation work?

How are Biotech Drugs Developed?

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