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Articles Tagged "design control"

25 Considerations for Companies Seeking Clarity in Design Controls

by BONEZONE | Sep 2018

OEMs must be aware of and comply with design control requirements included in 21 CFR, Part 820. Unsafe, ineffective devices are often the result of informal development that does not ensure proper establishment and assessment of these requirements. ... Read more »

Making a Device Design Change? Document These Critical Steps

by BONEZONE | Jun 2018

No matter where you are in the design process and no matter your internal procedures, control and documentation of design change is critical for safe and effective products.... Read more »

The Medical Device Labelling Process Needs to Start Early in Design Controls

by BONEZONE | Mar 2018

Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can take several steps to minimize these mistakes — it comes down to being in control.... Read more »

Proving Your New Design is Production Equivalent

by BONEZONE | Jun 2017

Design validation is essential to new product development, especially when using multiple suppliers to manufacture your device. Our experts weigh in on how to determine your product is production equivalent.... Read more »

Class II Design Problem Solved with Simulation

by Eric Lintula | Oct 2016

Many articles generalize design controls, but few provide direct application. This article offers a broad overview for engineers and their managers to highlight the milestones of a design process from design request to purchase order, using Finite Element Analysis.... Read more »

8 Design Control Issues Found During FDA Inspections

by John Gagliardi | Nov 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Fundamentals of a Human Factors Program

by Hannah Corcoran | Oct 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Outlines Critical Quality Measures

by BONEZONE | Sep 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

How to Proceed When a Testing Standard Doesn’t Exist

by Carolyn LaWell | Jul 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Controls: A 17-Year Learning Curve

by John Gagliardi | May 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design for Manufacturability: Meeting the Needs of the Missing Customer

by Sean Miller | May 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Synergetic Dissimilarity: Design Validation/Verification and Process Validation

by John Gagliardi | Mar 2014

Verification and validation are commonly confused. John Gagliardi defines the intertwined engineering tools and outlines how they are practiced.... Read more »

The Anatomy of a Successful Design Plan

by Robert Packard | Oct 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

How to Avoid Major FDA Inspection Mistakes

by Robert Packard | Jul 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Control Hot Buttons to Expect During an FDA Inspection

by John Gagliardi | May 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Complaints: A Second Chance to "Make it Right"

by BONEZONE | Oct 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Quality by Design: Incoming Acceptance Activities of Purchased Materials

by John Gagliardi | Aug 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

BSI Enhances its Medical Device Training Curriculum with RABQSA

by BONEZONE | Sep 2011

RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality... Read more »

Design Controls: Design Transfer, Changes and the Design History File

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Controls: Design Verification and Validation

by BONEZONE | Sep 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Controls: Design Review

by BONEZONE | Jun 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »