Enhancing Safety and Compliance in Syringe Manufacturing: A Study of Risk Management Strategies Based on ISO 14971
Akash Sharma, Chandra Prakash, Ankur Vora
Journal of Advances in Medical and Pharmaceutical Sciences · pp. 57–78 · Published 3 Aug 2024
10.9734/jamps/2024/v26i7702Abstract
Ensuring the safety and compliance of syringes is crucial in the medical device industry to mitigate risks and uphold quality standards. This research paper examines effective risk management strategies for syringe manufacturers, grounded in the principles outlined in ISO 14971. The ISO 14971 standard provides a systematic framework for identifying, evaluating, and controlling risks throughout the product lifecycle. By integrating these strategies into manufacturing processes, syringe manufacturers can enhance product safety, achieve regulatory compliance, and improve overall quality. This study synthesizes current practices and case studies to illustrate the practical application of ISO 14971 in enhancing safety and compliance within the syringe manufacturing industry.
References (14)
- 1 Risk assessment and risk management: Review of recent advances on their foundation [DOI]
- 2 Product Recalls in the Medical Device Industry: An Empirical Exploration of the Sources and Financial Consequences [DOI]
- 3 Medical Device Recalls and the FDA Approval Process [DOI]
- 4 Postmarketing Surveillance of Medical Devices — Filling in the Gaps [DOI]
- 5 Risk - A Multidisciplinary Introduction [DOI]
- 6 Medical devices—Application of risk management to medical devices [DOI]
- 7 A Comprehensive Review of Risk Management in the Medical Device Industry [DOI]
- 8 Importance of Risk Communication and Risk Analysis in Medical Device Industry [DOI]
- 9 The role of product life cycle in medical technology innovation [DOI]
- 10 Role of Regulatory Affairs in a Medical Device Industry [DOI]
- 11 Introduction to System Risk in Medical Device Design [DOI]
- 12 Injecting Quality Care: Syringes and their Impact on Precision Medicine in Healthcare [DOI]
- 13 A review of success factors in NPD: medical device domain
- 14 The Effective Approach of Managing Risk in New Product Development (NPD) [DOI]
Cited by 1
Akash Sharma, Chandra Prakash, Ankur Vora · Microbiology Research Journal International · 2024
Related research
- Drug Interactions, Safety and Efficacy of Probiotics — shares topic coverage
- Occupational Hazards and Safety Practices of Refuse Collectors in Obio/Akpor Local Government Area of Rivers State — shares topic coverage
- Prevalence of Falls and Associated Factors among Construction Workers in Port Harcourt, Nigeria — shares topic coverage
- Effects of Government Actions on Safety and Security Perceptions of International Students during COVID-19 Pandemic in China — shares topic coverage
- Efficacy and Safety of Labor Induction by Oral Versus Vaginal Misoprostol: A Randomized Controlled Clinical Trial — shares topic coverage
Article metrics
Real usage data collected on this platform.
20
Page views
0
PDF downloads
2
Outbound clicks
1
Citations
Views over time
Views by country
Approximate, from request IP at view time — not citizenship or institution. Countries with fewer than 5 views are grouped as "Other".
Traffic sources
Referring site, by host.
Views and downloads exclude known bots/crawlers. Citations combines this platform's own DOI-resolved index with each external source's own reported total — see Cited by above for individually listed citing works. Last refreshed 0 seconds ago.