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.”

Jul 8, 2014

Are You Ensuring Supplier Quality?

"Everyone cares about quality. Just ask them. However, unless someone actively measures quality performance, you must question the commitment to improvement."

Supplier management is a process getting much more scrutiny from notified bodies and regulatory agencies these days. The process includes establishing supplier criteria, evaluating capabilities, selection and ongoing monitoring of suppliers. It starts early in the development activity of the product or service where the requirements and/or specifications are outlined, and progresses through the evaluation and selection through ongoing monitoring and support. The application of supplier management depends on the nature and risk associated with the product or services being purchased and/or received.  

Jul 3, 2014

Listening and Being Heard are Important to Regulated Companies

Listening and Being Heard are Important to Regulated Companies
Listening to customers is at the core 
of product development for MasterControl.

by Brian Curran
Senior Vice President, Product Management and Strategy, MasterControl Inc.

If you’re wondering why your company should listen to your customers, or why as a customer you should be heard, just think of Twitter. Twitter and hashtags seem synonymous. But hashtags didn’t exist until a user suggested it in 2007. It took two years before Twitter, which was founded in 2006, started hyperlinking hashtags.

Jul 1, 2014

Happy Employees Matter

Every year, Fortune Magazine publishes a list of the top 100 companies to work for. These companies are well known for how well they treat their employees. In 2005, Deloitte Consulting decided to see if there was a correlation between a positive work environment and corporate success. They tracked the shareholder returns of the 56 publicly traded companies on Fortune’s 2005 list of best companies to work for. According to this study, these companies not only consistently beat the S&P 500, but “walloped it.” Companies that have happy employees apparently have a better chance of success than those who don’t. As Deloitte principle Bob Dalton explained, “This puts real data on something that seems intuitively true.” *

Jun 26, 2014

Changes to China’s Medical Device Law Take Effect This Month; Here’s What You Need to Know.

Changes to China’s Medical Device Law Take Effect This Month; Here’s What You Need to Know.
by Lisa Weeks, Marketing Communications, MasterControl
On March 31, 2014, the Chinese State Council unveiled its amended “Regulations for the Supervisions and Administration of Medical Devices,” aka State Council Decree No. 650. The amended decree, which went into effect on June 1, 2014, will be enforced by the U.S. Food and Drug Administration’s counterpart in China, the China Food and Drug Administration (CFDA), formerly known as the State Food and Drug Administration (SFDA). While many industry observers have characterized the CFDA as being unnecessarily complicated and intentionally ambiguous, the modernization of its fourteen-year-old medical device law suggests that Chinese regulators are finally making strides to facilitate the device approval process, while simultaneously cracking down on overpricing and corporate malpractice. In this post, we’ll compare the updated decree to the original and discuss how the new regulations will impact manufacturers hoping to break into China’s lucrative medical device market.

Jun 24, 2014

Creating a Global Regulatory Plan

Having and maintaining strong global regulatory strategy and plans can help your business not only stay in compliance but can be an integral part of corporate market growth strategies.  How many of us have jumped into a new market before fully understanding the regulatory requirements and the potential impact of those requirements?  If you have, you are not alone.  Mapping the requirements as part of your strategic planning may help you identify a great new market or help you avoid a costly mistake.

Jun 19, 2014

Partnering with Quality Professionals Worldwide

MasterControl has grown our reach significantly over the last 10 years—from a small provider of a narrowly focused document control product to one of the largest organizations in the world focused on helping quality and compliance professionals achieve their purpose.  I have met with many of the world’s top quality professionals over the past 10 years and I have been amazed by their devotion and commitment.  I have recently found myself asking the question:  What drives these dedicated people?  Why are they so passionate about their jobs?   I believe I have found the answer and it has had a strong effect on how I view MasterControl’s mission. 

Jun 17, 2014

3 Common Cybersecurity Mistakes in Pharma (and How to Avoid Them)

3 Common Cybersecurity Mistakes in Pharma (and How to Avoid Them)
Information security deserves full attention 
throughout pharma and life sciences companies

by Jim King, Senior VP of Technical Support & Infrastructure, MasterControl Inc.

Due to the ever-rising position of information as a valuable commodity, organizations must take steps to protect their data. For pharma and life sciences companies, the question is not if their digital data will be compromised, but when. Here are three common security mistakes made by enterprises and ways to avoid those mistakes by focusing on employee behavior.