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Breaking into Quality and Risk Management

R

rbeech

#1
I am a physician, that also has a legal education, and I am looking into doing some quality and/or risk management work in the medical device field and would like some advice as to how to begin. What type of classes would you suggest? Are there any certifications that one needs to do quality/risk management? Any certifications are strongly suggested? What are some of the best companies to work for in the field of medical device quality/risk management?

Thanks in advance for any help.
 
#2
I am a physician, that also has a legal education, and I am looking into doing some quality and/or risk management work in the medical device field and would like some advice as to how to begin. What type of classes would you suggest? Are there any certifications that one needs to do quality/risk management? Any certifications are strongly suggested? What are some of the best companies to work for in the field of medical device quality/risk management?

Thanks in advance for any help.
I'm curious. Do you expect to do this work as an adjunct to being a medical doctor or instead of being a practicing physician?

When you say "legal education," do you mean you have a degree in law or just some courses under your belt? Have you ever been admitted to a bar [at law, not a saloon] in any state? Do you think you'd like to be on one company's payroll or work as an independent consultant, albeit with a firm of independent consultants? Do you expect to travel to job sites or do everything long distance (i.e. review products or documents in your own facility?)

In terms of certification, the exact nature of what specific function you intend to perform will determine that. Many organizations in the medical device field need someone to weave through the intricacies of both international and individual political subdivision regulations as they offer products and services for sale. Sometimes, a background and experience in international law is helpful, but does not require admission to practice as an attorney, since an attorney of record in the venue is often used to actually appear in court proceedings or filings.

A very big field is product liability - both preventative before the product is offered for sale and defensive - when the product is accused of causing injury. Both legal and medical backgrounds would come in handy here.

Tell us more about yourself and your situation so we can better focus on helping you.
 

somashekar

Staff member
Super Moderator
#3
I am a physician, that also has a legal education, and I am looking into doing some quality and/or risk management work in the medical device field and would like some advice as to how to begin. What type of classes would you suggest? Are there any certifications that one needs to do quality/risk management? Any certifications are strongly suggested? What are some of the best companies to work for in the field of medical device quality/risk management?

Thanks in advance for any help.
Hello Doctor, Greetings and Happy new year 2010 ...
Knowledge from experts like you in specific field is a vital input to risk management. The attachment can be of good use to you added with your knowledge and experience. Also get a copy of ISO 14971 and have a good look into it...
 

Attachments

R

rbeech

#4
Thank you Mr. Bucey,

In the way of more background I actually have an MD, a JD and an MBA (in finance). I obtained my MD first, followed by a general surgery residency. I then obtained my JD and have not taken a bar exam although may take Texas' next year. My MBA in finance followed.

I just spent five years in the medical device industry where I worked for a major orthopedic company and left that position, as director of emerging technologies and professional education, for a chief medical officer position in Houston. I am considering a return to the corporate world and would love to do so in the role of quality or risk as I feel those positions hold the best opportunity to leverage my medical and legal training. I would consider one company or a consultant role as long as there was challenge and a clear path for advancement. Travel is a passion of mine, thus international issues of quality and risk appeal to me, but must be tempered with the demands of a growing family.

The liability field is one that I have considered often and the opportunities I see there lie mostly as choosing one side or the other and being an expert in litigation - something that I have done part-time thus far (as a consultant) and may do one day full-time. I have not really identified or explored these opportunities as they relate to preventative issues but that is an intriguing option.

Thank you again for your help!
Richard
 

Antonio Vieira

Involved - Posts
Trusted
#6
Perhaps using the recent ISO 31000:2009 Risk Management and IEC 31010:2009 Risk Management - Risk Assessment Techniques, will be a good idea.
:)
 

Marcelo

Inactive Registered Visitor
#7
Perhaps using the recent ISO 31000:2009 Risk Management and IEC 31010:2009 Risk Management - Risk Assessment Techniques, will be a good idea.
This is not a very good point. ISO 31000 is for enterprise risk management, not product risk management, and also has imcompatibilities with ISO 14971, which is widely used in medical devices regulations.
 
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