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Medical Device Industry

The “Medical Device Industry” category at AssurX focuses on the unique needs and challenges of this highly regulated sector. This section provides insights into quality management, regulatory compliance, and process optimization specifically for medical device manufacturers. Topics include navigating complex regulations, ensuring product safety, and improving operational efficiency. With AssurX’s expertise, medical device professionals can maintain compliance, enhance quality, and drive innovation, ensuring products meet stringent industry standards.

6 04, 2023

Key Priorities for Proactive EHS Risk Management
Key Priorities for Proactive EHS Risk Management

Key Priorities for Proactive EHS Risk Management

By Stephanie Ojeda|2024-03-12T13:26:55+00:00April 6th, 2023|Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

In 2021, the U.S. Occupational Safety and Health Administration (OSHA) conducted [...]

31 01, 2023

Tips for Preparing for an ISO Certification Audit
Tips for Preparing for an ISO Certification Audit

Tips for Preparing for an ISO Certification Audit

By Stephanie Ojeda|2024-06-03T14:12:38+00:00January 31st, 2023|Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Recent ISO data shows a growing number of certificates being issued across all s [...]

19 01, 2023

An Overview of the FDA Draft of CSA Guidance for Quality Systems
An Overview of the FDA Draft of CSA Guidance for Quality Systems

An Overview of the FDA Draft of CSA Guidance for Quality Systems

By Stephanie Ojeda|2023-01-19T10:01:40+00:00January 19th, 2023|Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

In September 2022, the (FDA) released draft computer systems assurance (CSA) gui [...]

12 01, 2023

6 Common Reasons External Quality Audits Fail
6 Common Reasons External Quality Audits Fail

6 Common Reasons External Quality Audits Fail

By Stephanie Ojeda|2024-03-26T20:24:48+00:00January 12th, 2023|Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

In FDA and ISO environments, quality audits are a process of examination and sub [...]

3 01, 2023

Root Cause Analysis Tools: Which Should You Use?
Root Cause Analysis Tools: Which Should You Use?

Root Cause Analysis Tools: Which Should You Use?

By Stephanie Ojeda|2024-01-13T02:12:13+00:00January 3rd, 2023|Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Root cause analysis is a common weak spot in manufacturing, causing numerous qua [...]

29 11, 2022

How Hybrid Audits Can Help MDR Compliance in the European Union
How Hybrid Audits Can Help MDR Compliance in the European Union

How Hybrid Audits Can Help MDR Compliance in the European Union

By Stephanie Ojeda|2022-11-29T08:48:10+00:00November 29th, 2022|eMDR, EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]

15 11, 2022

8 Essential CAPA KPIs to Measure
8 Essential CAPA KPIs to Measure

8 Essential CAPA KPIs to Measure

By Stephanie Ojeda|2024-07-01T21:28:46+00:00November 15th, 2022|Corrective Action (CAPA), FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Corrective and preventive action (CAPA) is a core function in any quality manag [...]

2 11, 2022

Finding the Root Cause: Where Manufacturers Go Wrong
Finding the Root Cause: Where Manufacturers Go Wrong

Finding the Root Cause: Where Manufacturers Go Wrong

By Stephanie Ojeda|2024-03-04T21:11:44+00:00November 2nd, 2022|FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]

12 10, 2022

5 Strategies to Improve Quality Incident Management and Root Cause Analysis
5 Strategies to Improve Quality Incident Management and Root Cause Analysis

5 Strategies to Improve Quality Incident Management and Root Cause Analysis

By Stephanie Ojeda|2024-01-13T02:20:40+00:00October 12th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]

5 10, 2022

AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables

AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables

By Tracy Orlick|2022-10-05T06:31:55+00:00October 5th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality mana [...]