What is Medical Device?

According to the definition in ISO 13485 (2003) medical device is an instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) such as

Diagnosis, prevention, monitoring, treatment.

Supporting or sustaining life.

Control of conception

Disinfection of medical devices

In the year 1997 FDA introduced design control regulations and all medical device manufacturers have to comply to them to sell their products in the USA, these rules if not followed call for FDA enforcement actions such as “FDA 483’s” but on another side full compliance has many positive results such as :

Lesser MDR’s

Fewer customer complaints

Lesser manufacturing deviations

Faster time to market

Why Six Sigma in Medical Device Design?

Observed that even full compliance to design control regulations brought only short-term profits and growth, so the question arises how can medical device design companies gain long-term growth, full compliance with FDA’s design regulations, release good quality products and compete with other industries.

Six Sigma is the answer and solution to all questions as mentioned above as use of six sigma tools and techniques by medical device design companies can deliver superior products with minor defects in their products and processes which will result in more significant profits and growth of such groups. The growth and profitability can then be tracked using Six Sigma methodologies again. Six Sigma in business improvement certification courses come to the rescue here.

HIGHLIGHTS OF THIS COURSE AND CERTIFICATION PROGRAM

Brainmeasures mastering six sigma in medical device design course and certification is an excellent source of information for managers of this field,

This course gives a practical view of the design of six sigma as a management philosophy.

This course will teach you how to implement FDA’s design control requirements in the competitive business environment.

This course focuses on how to implement six sigma in medical device design companies.

Will clear all your doubts regarding six sigma and its tools and techniques

In-depth and detailed knowledge of the subject.

Focuses on the leadership role in ensuring success.

This course will teach its candidates six sigma roadmap for product and process development.

“So, the bottom line is that proper six sigma implementation in medical device design industries will lead to huge profits and very few defects which will impact the overall growth of these companies and this course is a must for all those associated with this field. Managers and company heads of medical device design industries must take this course to eliminate defects from their system and in turn, bring positive results and profits.”

With the changing industry trends, many sales employees in the medical device design companies are also opting for Six Sigma Financial Tracking and Reporting certification courses. Because Sales Forecasting has emerged as a very significant part of an employees profile and this course helps them do just that!

Who will Benefit from this course and Certification Program

This course and certification will benefit

Business Managers

Technology/Engineering

Manufacturing Managers

Quality Managers

Regulatory

Sales and Marketing