Medical Devices quality assurance
122 views | +0 today
Follow
Your new post is loading...
Your new post is loading...
Scooped by 40 Hours
Scoop.it!

Blogs worth reading - creo Quality

creo Quality has a
couple of excellent blog posts worth checking out, first off is Fast and Furious Medical Device Product Development: 
Ten
months ago, I started a medical device product development project with an
entrepreneur / CEO.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

The Shutdown: An Update on FDA Activities

The Shutdown: An Update on FDA Activities | Medical Devices quality assurance | Scoop.it
By Kurt R. Karst –      
We’re now entering the second week of the shutdown of the federal government (or “the lapse period” as some have called it), and there does not appear to be an end in sight.  In fact, the environment in Washington, D.C.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

CDRH Learn (Spanish): Overview of Regulatory Requirements: Medical Devices | U.S. Radio News

CDRH Learn (Spanish): Overview of Regulatory Requirements: Medical Devices - ... http://t.co/7fOkARu4ER #FoodandDrugAdministration #health
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

CDRH Issues Draft Guidance on the Applicability of GLPs in Device Submissions

CDRH Issues Draft Guidance on the Applicability of GLPs in Device Submissions | Medical Devices quality assurance | Scoop.it
By Allyson B. Mullen – On August 28, 2013, FDA’s Center for Devices and Radiological Health issued a draft guidance, “The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers.”  This new, short guidance...
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

CDRH Articles and Resources | Creating the Center for Digital Research in the Humanities

CDRH Articles and Resources | Creating the Center for Digital Research in the Humanities | Medical Devices quality assurance | Scoop.it
RT @trevormunoz: Kay Walter mentions @CDRH_UNL's model Promotion and Tenure Guidelines http://t.co/uPnC7UsYZM #DHatCU
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Roadmap to ISO 13485 Certification: Planning the Quality Management System

my page description. (Planning to certify to ISO 13485? Here's how to get started.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Upcoming IDE Tracking Improvements

On Aug. 18, 2013, CDRH will update their system used to process IDE and Emergency Use Authorization submissions. http://t.co/kwVsdxBMTk
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff

CDRH/OSEL CBER
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

FDA Issues Final Guidance on Radio Frequency Wireless Technology in Medical Devices

FDA Issues Final Guidance on Radio Frequency Wireless Technology in Medical Devices | Medical Devices quality assurance | Scoop.it
By Jennifer D. Newberger – An increasing number of devices employ radio frequency wireless technology. This trend is likely to continue. These devices present some new technological issues. To respond to these new issues, FDA has just released...
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Small company's culture

Small company's culture | Medical Devices quality assurance | Scoop.it
Something known about company’s culture. Organizational culture represents the principles that a group develops to address the problems of adaptation to the external context and integration of its internal environment.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

CDRH to Update IDE, EUA Electronic Submissions System - FDA news (subscription)

CDRH to Update IDE, EUA Electronic Submissions System
FDA news (subscription)
CDRH to Update IDE, EUA Electronic Submissions System.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Implementing the ISO 13485 Standard: Objectives «

Implementing the ISO 13485 Standard: Objectives « | Medical Devices quality assurance | Scoop.it
Author discusses implementing the ISO 13485 standard, including 7 questions to clarifying your objectives and 6 considerations in shaping your objectives.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Does ISO 13485 have a Periodic Document Review Requirement?

Does ISO 13485 have a Periodic Document Review Requirement? | Medical Devices quality assurance | Scoop.it
Does ISO 13485 have a Periodic Document Review Requirement? ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems (Does ISO 13485 have a Periodic Document Review Requirement?: Hi, First off, this is a great forum; I can’t bel...
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Elsevier Business Intelligence (EBI) Will Host 'IN3 Medical Device 360 Summit ... - Marketwired (press release)

Elsevier Business Intelligence (EBI) Will Host 'IN3 Medical Device 360 Summit ... - Marketwired (press release) | Medical Devices quality assurance | Scoop.it
Elsevier Business Intelligence (EBI) Will Host 'IN3 Medical Device 360 Summit ...
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

FDA issues final guidance on risk-based approach to monitoring clinical ... - Lexology (registration)

FDA issues final guidance on risk-based approach to monitoring clinical ... - Lexology (registration) | Medical Devices quality assurance | Scoop.it
FDA issues final guidance on risk-based approach to monitoring clinical ...
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

How outsourcing design can be a sustainability cop-out - GreenBiz.com (blog)

How outsourcing design can be a sustainability cop-out - GreenBiz.com (blog) | Medical Devices quality assurance | Scoop.it
GreenBiz.com (blog) How outsourcing design can be a sustainability cop-out GreenBiz.com (blog) Then the ODMs started designing phones, high-end servers, networking equipment, instrumentation -- all sorts of consumer electronics and even medical...
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Is mHealth the Future? [Infographic]

Is mHealth the Future? [Infographic] | Medical Devices quality assurance | Scoop.it
With over 97,000 health and fitness mobile apps on Google Play and the Apple App Store and the top ten apps generating up to four million downloads daily, it is impossible to deny the popularity of mobile health.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

FSMA and Third-Party Audits: What is a “Serious Risk to the Public Health?”

FSMA and Third-Party Audits: What is a “Serious Risk to the Public Health?” | Medical Devices quality assurance | Scoop.it
By Ricardo Carvajal – In poring over FDA’s recently issued proposed rule on Accreditation of Third Party Auditors (see our prior post here), one thing that caught our eye is FDA’s discussion of FSMA’s notification requirement for auditors. That...
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Class Act: Status Of CDRH’s 515 Initiative :: “The Gray Sheet” :: Elsevier Business Intelligence

RT @GraySheet: Class Act: Status Of CDRH’s 515 Initiative http://t.co/KwNyd88gNU
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

CDRH New Update

CDRH New Update | Medical Devices quality assurance | Scoop.it
CDRHNew Date: August 19, 2013 The following new items were added to the CDRH web pages on August 16, 2013. Previous CDRH New Items can be found on the CDRHNew Page [...
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

New FDA Draft Guidance for Medical Foods Suggests that Some Common Products and Certain Label Statements Violate FDA Regulations

New FDA Draft Guidance for Medical Foods Suggests that Some Common Products and Certain Label Statements Violate FDA Regulations | Medical Devices quality assurance | Scoop.it
By Etan Yeshua – Earlier this week, FDA provided new insight into its interpretation of the definition and regulation of medical foods — a legal category established by the Orphan Drug Act of 1988, incorporated into the Federal Food, Drug, and...
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

AAPM: a focus on quality assurance - Medical Physics Web (subscription)

AAPM: a focus on quality assurance - Medical Physics Web (subscription) | Medical Devices quality assurance | Scoop.it
AAPM: a focus on quality assurance Medical Physics Web (subscription) Modus Medical Devices was previewing its QUASAR Automated Delivery QA (ADQ) software.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner - Webinar by GlobalCompliancePanel | Webinar Central

Start: 09/19/2013 10:00 am End: 09/19/2013 11:00 am Timezone: US/Eastern Overview: A document control system is required for compliance with federal (FDA) and international (ISO) compliance.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

'Manufacturing 2.0' finds home in New York - Regina Leader-Post

'Manufacturing 2.0' finds home in New York - Regina Leader-Post | Medical Devices quality assurance | Scoop.it
Regina Leader-Post 'Manufacturing 2.0' finds home in New York Regina Leader-Post Together with their friend Marcel Botha, an entrepreneur who makes medical devices, they sketched up a new spoon that "front-loads" the food, leaving less uneaten.
more...
No comment yet.
Scooped by 40 Hours
Scoop.it!

CDRH New Update

CDRH New Update | Medical Devices quality assurance | Scoop.it
CDRHNew Date: August 9, 2013 The following new items were added to the CDRH web pages on August 8, 2013. Previous CDRH New Items can be found on the CDRHNew Page [...
more...
No comment yet.