FEATURED EDITORIAL
Closing The Perception-Vs.-Reality Gap In CGMP Quality Culture And Compliance
This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.
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UDI At The Point Of Use: Should You Implement Direct Marking Now?
Looking at the FDA and MDR compliance deadlines for UDI marking can be deceiving. The intense knowledge buildup, planning, and supply chain preparation efforts necessary, along with internal procedure readiness and process changes, require a long lead time.
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Incorporating Privacy By Design & Security By Design Into Medtech Development
Medical device companies need to act now to demonstrate their products' cyber resilience and privacy capabilities, not simply to address the myriad of compliance and data privacy regulations but also to establish patient and caregiver confidence in their products.
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Making FMEA More Robust With HACCP
Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.
INDUSTRY INSIGHTS
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Improving Health Outcomes With Personalized Apps
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.
MED DEVICE ONLINE CONTENT COLLECTIONS
This ebook is a collection of articles from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.
More Content CollectionsLATEST HEADLINES
- MTD Micro Molding Doubles Manufacturing Space
- Overcoming Difficult Cleaning Residues In Life Sciences Webinar Announced For October 22
- Viveve Announces Positive Primary Efficacy Data From Its SUI Feasibility Study And Positive Preclinical Outcomes That Support The Company’s New Sham Tip For Pivotal Pursuit Trial
- Elbit Systems Of America Subsidiary Selected For Evaluation Of U.S. Navy Ventilator To Combat COVID-19
- Quartic.ai Announces Partnership With Sparta Systems To Connect Real-Time Manufacturing Insights To QMS
- Automated Inspection Technologies For Vial And Syringe Fill-Finish Webinar Announced For June 24
- Qosina Provides Cost-Effective Off-The-Shelf And Custom Tubing
- PTI Engineered Plastics Responds To PPE Shortage
EVENTS
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Managing Safety, Regulations and Issues Related to COVID-19
September 22, 2020
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Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance
September 22 - 22, 2020
1pm-2:30pm EDT, Online Training Price: $299 - Includes Bonus Handouts!
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Leadership Development for Executive Assistant
September 24, 2020
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Medical Device Manufacturing & R&D Summit
September 24 - 25, 2020
Las Vegas, NV -
VIRTUAL MEDICALL - EXCLUSIVE ONLINE EPXO ON "TELEMEDICINE, HOME HEALTHCARE AND REMOTE MONITORING SOLUTIONS"
September 25 - 26, 2020
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Use Microsoft Outlook to Its Fullest Extent: Tips, Techniques and Best Practices
September 25, 2020
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Filing IRS Form 1099-NEC & W-9 Update - Complying with IRS Information Reporting
September 28, 2020
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HIPAA 2020: Texting, Emailing, And Personal Devices - New Guidance
September 29, 2020
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3-Hour Virtual Seminar: SOP Writing, Training and Compliance in the Pharmaceutical Industry
October 5, 2020
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Discover the Impact of SDA (Same Day ACH) with Changes in 2021
October 5, 2020
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INCOTERMS 2020 Made Easy - Decoding your Shipment
October 7, 2020
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Creating Optimal Sampling Plans
October 7, 2020
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Excel - The Business Intelligence Toolkit - Pivot Tables Beyond The Basics
October 7, 2020
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Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
October 8, 2020
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Drug Delivery Partnerships
October 12 - 14, 2020
Orlando, FL