Aug 21, 2014

Regulatory Records Primer Part 1: Decoding the Requirements for Medical Device Manufacturers

Regulatory Records Primer Part 1:  Decoding the Requirements for Medical Device Manufacturers
Records, either paper or electronic,play a vital 
role in FDA’s ability to confirm that procedures 
have been appropriately implemented 
by Les Schnoll
Quality Docs, LLC


The Quality System Regulation (QSR) is premised on the theory that the development, implementation, and maintenance of procedures designed to carry out the requirements of the regulation will assure the safety and effectiveness of medical devices.  Therefore, it is easy to see the importance of the records required to document the implementation of those quality system procedures.
One of the basic themes of the Quality System Inspection Technique (QSIT) (used during inspections of medical device manufacturers) is the “Establish Test.”  The QSR requires many procedures to be “established” and defines “establish” as “define, document (in writing or electronically), and implement.” 

Aug 19, 2014

Industry Expertise Sets MasterControl Apart from Competition

by James Jardine, Marketing Communications, MasterControl

Over the past two decades, MasterControl has flourished to become one of the world’s foremost providers of quality management software solutions and services. But innovative technology is not the only driver behind the QMS leader’s prosperity. In fact, it is the industry experience of MasterControl’s knowledgeable personnel that is the guiding force that propels the company’s continued growth worldwide.
Industry Expertise Sets MasterControl Apart from Competition
Discover how industry expertise motivates 
MasterControl to help customers succeed.

Approximately one-third of MasterControl’s staff comes from backgrounds in the business sectors that it serves, such as pharmaceutical, medical device, and general manufacturing industries. MasterControl has sought out the best and the brightest in these and other related fields to help develop and refine software and services that facilitate customer success. The know-how, familiarity, and empathy these experts have to offer helps MasterControl better steer the development of its products toward meeting customer needs because they have walked in the customers’ shoes. They understand the trials and complications of quality management, which makes them well qualified to provide the tools that can help quality professionals automate and simplify their tasks. Plus, they share the same goals and passion for their work as the regulatory and quality professionals that use MasterControl applications on a daily basis.

Aug 14, 2014

Medical Device Development: Thinking Globally, Acting Locally

Medical Device Development: Thinking Globally, Acting Locally
From a Medtech development standpoint, 
thinking globally  when developing the
“get-to-market” strategy for your device 
product needs to become the rule. 

by Timothy Blair, Director, Global Business Development, NAMSA and Seth J. Goldenberg, PhD, Senior Principal Scientist, NAMSA

Introduction: Medtech and the Healthcare Landscape
The global healthcare and healthcare service market will maintain steady growth due in large part to an aging population that is living longer and to improved healthcare services in emerging markets that include China, Brazil, India, Japan, Israel, and South Korea, among others. It is interesting to note that countertrends seem to be developing in the medical device space; for example, hospital utilization of medical devices has slowed significantly, reimbursements continue to tighten, and there was a first-time global decrease (5%) in US premarket approvals (PMAs) in 2012, a trend that continued into 2013. There were also fluctuations in investor healthcare spending across 2012, drops in mergers & acquisitions deal value and deal counts, and a device tax that is adding to the squeeze.

Aug 12, 2014

Certification: Is It Worth the Hassle?

Certification: Is It Worth the Hassle?
The road to certification can 
be irritating and upsetting.

by Lisa Weeks, 
Marketing Communications, MasterControl
In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process.

Aug 7, 2014

Version 11 of MasterControl Features More New Enhancements than Any Previous Release

by James Jardine, Marketing Communications, MasterControl
The recently released version 11 of MasterControl software dramatically accelerates customers’ ability to deliver life-changing products to those who need them most. Constructed largely in response to customer input, MasterControl v11 includes 560 new enhancements and represents more than 65,000 man hours of software engineering.  

A new website tells the complete story of MasterControl v11. 
Version 11 of MasterControl Features More New Enhancements than Any Previous Release
“How often do you hear companies say, ‘We heard your suggestions and complaints, so we improved the product’?” said Brian Curran, MasterControl Senior Vice President of Strategy and Product Management. “MasterControl Version 11 is better, bigger, and faster because we listened to our customers.”
With a focus on improving the overall customer experience across all touch points, the new v11 release is intended to make it easier for the basic user to take advantage of all of the software system’s functionality. In addition to improving ease of use, MasterControl v11 drastically enhances scalability, security, and accessibility.

Aug 5, 2014

5 Ways to Cut Medical Device Development Time with Embedded Design Teams

5 Ways to Cut Medical Device Development Time with Embedded Design Teams
 While designers are embedded in a clinical environment, 
embedding a clinician on-staff with a design team 
also improves the availability of feedback.
by Chris HammondDirector of Insight & Innovation, Kaleidoscope and Sean J. Barnett, MD, MS, FACS, FAAPChief Medical Officer,

Overcoming regulatory pitfalls of medical device development with early clinical involvement.
For medical product development, the rigors of input gathering and iterative concept testing may slow down innovation process and subsequently increase costs. Building on user-centered design principles, creating an Embedded Design Team with clinicians and design professionals in a co-creation atmosphere provides a revolutionary way to drive speed to market.  

Jul 31, 2014

Questions All Auditor Should Ask: The Use and Misuse of Audit Checklists

Questions All Auditor Should Ask: The Use and Misuse of Audit Checklists
There's nothing like a good checklist
---as long as you use it properly!
by Laurie Meehan, Polaris Compliance Consultants, Inc.

With contributions from Celine Clive, Polaris Compliance Consultants, Inc.,
Lisa Olson, PAREXEL International, and Linda Borkowski, Independent Compliance Consultants

There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist.  It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: “Why?”  So how can you develop the best checklists possible and avoid relying on them too heavily?

Jul 29, 2014

Current Issues in Medical Device Risk Management


Medical devices have been developed with some requirements for product safety since the implementation of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.  Initially FDA required manufacturers to submit information related to safety as part of the 510(k) premarket notification process, providing comparative data on predicate devices versus the device under consideration.  In the more rigorous Premarket Approval (PMA) process, more detailed safety information on the device under consideration has been required.  Additionally, in a guidance document published in 1991, the FDA required a “hazard analysis” in all premarket submissions for devices containing software.

As far back as 1986, risk analysis was required to receive the CE Mark in Europe.  In 1994, with the implementation of Europe’s Medical Device Directive under the Essential Requirements section of the law, product safety information was required and a European standard was developed to conduct risk analysis for devices under consideration, EN 1441. That standard began a push to develop an international standard for risk, which eventually became ISO 14971 on risk management, released in 2000, and revised in 2007.

Jul 24, 2014

How to Conduct Better Effectiveness Checks and Management Reviews within Your CAPA Process

How to Conduct Better Effectiveness Checks and Management Reviews within Your CAPA Process
More "effective" effectiveness checks 
can help you close more CAPAs.
by Lisa Weeks, Marketing Communications, MasterControl
In the final segment of a three-part QEM/CAPA webinar series, quality expert Ken Peterson discusses the importance of effectiveness checks within the CAPA process. He also explains the difference between process verification and process validation, and why knowing which process to use (and when to use it) is paramount to a successful CAPA methodology. Peterson closes the webinar by summarizing the current models and best practices being used in management review, data collection, and charting to enhance CAPA decision making in all areas of your business. This is a summary of that discussion. If you wish to view the webinar in its entirety, please click on the link provided at the end of the post. 

Jul 22, 2014

Document Control 101: How to Comply with ISO and API Without Being Trapped by Your Own Words

Document Control 101: How to Comply with ISO and API Without Being Trapped by Your Own Words
Weasel words are hand-picked to help you comply 
without getting into trouble.  How could such an 
appealing creature have its character so maligned?
by Miriam Boudreaux,
Mireaux Management Solutions
Reprinted with permission.

Sometimes the interpretation of the ISO 9001 or API Q1 9th Edition/API Q2 requirements seem to force us to do things we won’t be able to do, or sustain for more than a few months— let alone days.  So how do we write our policies and procedures to explain our approach while avoid being trapped by our very own words?  Ah, here come the weasel words!
These words are hand-picked from the dictionary and carefully crafted in such a way that when inserted in your procedures, they may just help you comply without getting in trouble.

Jul 17, 2014

How the New FDA Final Rule and Guidance on Electronic Submissions Will Impact Devicemakers

The FDA Final Rule and Guidance Make 
eMDRS Mandatory Next Year.
by Lisa Weeks, Marketing Communications, MasterControl   
In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format, rather than in paper form through Form FDA 3500A. The “Final Rule” will take effect on August 14, 2015, which means you have only 13 months to revise your MDR procedures to comply with the new requirements and to secure a production account for submitting eMDRs to the FDA. Will you be ready?  

Jul 15, 2014

7 Steps to Respond to an FDA 483 Inspection Observation

7 Steps to Respond to an FDA 483 Inspection Observation
by Robert Packard, President, Medical Device Academy

Responding in 15 days is one of seven steps on how to respond to an FDA 483 inspection observation. This blog post also includes advice from a former FDA investigator. 

When an FDA investigator has an inspection observation, the investigator issues an FDA 483. This is the FDA’s form number. If your company receives an FDA 483, how you respond to the FDA 483 is crucial to avoiding a Warning Letter. In the words of Leo Lagrotte, a former FDA investigator I work with, “Many, many times I have seen an [Official Action Indicated (OAI)] classified inspection that had been recommended for a Warning Letter by the compliance branch be set aside based upon the response of the firm.”