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Related Concept Videos

Quality Assurance01:19

Quality Assurance

275
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
275
Quality Control01:05

Quality Control

453
Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
453
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

16
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
16

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

Omar Kheir1, Sam Smedts1, Alexis Jacoby1

  • 1Department of Product Development, Faculty of Design Sciences, University of Antwerp, Antwerp, Belgium.

Medical Devices (Auckland, N.Z.)
|October 27, 2021
PubMed
Summary

Medical device start-ups often lack quality management knowledge, hindering innovation. This guide provides documentation requirements for establishing a quality management system compliant with ISO 13485, aiding start-ups in their certification journey.

Keywords:
ISOcompliancedocumentationinnovationmedicalqualitystart-up

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Area of Science:

  • Medical Device Development
  • Quality Management Systems
  • Regulatory Compliance

Background:

  • Start-ups are crucial for medical device innovation but face significant challenges.
  • A primary limitation for these start-ups is a deficiency in understanding and implementing quality management systems.
  • This knowledge gap can impede product development and market entry.

Purpose of the Study:

  • To provide an overview and guideline for essential documentation.
  • To assist medical device start-ups in establishing a quality management system (QMS).
  • To ensure compliance with the ISO 13485 standard.

Main Methods:

  • A case study approach focusing on a specific medical device start-up.
  • Analysis of the ISO 13485 standard document.
  • Development of documentation requirements based on the case study and standard.

Main Results:

  • Identification of critical documentation needed for QMS implementation in start-ups.
  • A practical framework for navigating ISO 13485 requirements.
  • Demonstration of how a case study can elucidate standard requirements.

Conclusions:

  • Addressing the quality management knowledge gap is vital for medical device start-up success.
  • The proposed documentation guideline, based on ISO 13485 and a case study, can facilitate compliance.
  • This resource supports start-ups in achieving ISO certification and enhancing their quality management capabilities.