Medical Device Consulting 

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Industry advisers and consultants.
Emergo Group - Medical Device Quality Assurance Consulting
ISO 13485 & FDA GMP consultants for medical devices & IVD. Specialists in international medical device regulations. Offices worldwide. Since 1997.
About Emergo | All Services | Japan STED | GMP Consulting
www.EmergoGroup.com
Startup Operations - Medical Device Manufacturing Solutions
Assisting Medical Device and Pharmaceutical companies to implement simple and effective solutions for Operations and Manufacturing related issues.
www.startup-operations.com
Siemens - Medical Device Consulting
Siemens Healthcare technology helps improve patient outcomes and reduce healthcare cost. Siemens Answers for Healthcare
www.usa.siemens.com/answers
Medical Device Consulting
Quality Regulatory Experts put our expertise to work for you
www.AlvaMed.com
Medical Device Consulting
Consulting, Test and Certification for a wide array of medical devices
www.ntscorp.com
Med. Product Development
Full service engineering & contract manufacturing. Fortune 500 clients.
www.bctechinc.com
Six Sigma for Healthcare
Earn your Six Sigma Certification Online from Villanova. Free Info!
www.VillanovaU.com
Medical Consulting
Ensure You Continue to Deliver Quality Results & Stay Compliant
www.DecisionHealth.com/Consulting
Med Device Mfg Simulation
Software, Training, Implementation Optimize Your Manufacturing Process
www.pmcorp.com
Going to market?
Market positioning is critical. Get it right the first time.
www.curranandpartners.com
Medical Device Consulting
Experienced financial and marketing consulting in medical technology
www.EssHcc.com
SterlingTech Software
Your partner in Medical Device Software Development and Test
www.sterlingtechsoftware.com
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A-Z Medical Device Consulting Provider Directory
0-9 | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z
A
Arthur D. Little
Consulting firm which offers an integrated array of services in management consulting and technology and product innovation through offices in 30 countries worldwide.
www.arthurdlittle.com
B
Bridge Product Design
Product design and engineering consultancy for the consumer and medical markets, using CAD technology.
www.bridgedesign.com
Burd Consulting
Engineering biotech, medical, and plastic products. Located in Oakland, California.
www.burdconsulting.com
C
Curt Deckert Associates, Inc.
R&D consultants specializing in optics, light and imaging technologies.
www.cdeckert.com
Clark Consulting Group
Consulting in product engineering, manufacturing, and quality systems for disposable medical devices.
www.clarkgroup.net
Crestway Corp.
Consulting and design services for medical camera projects. Located in Titusville, Florida.
www.crestway.com
Crisp Information
Consulting in product and process development for medical device and in vitro diagnostic manufacturers and start-ups.
www.crispinfo.com
D
Designhaus, Inc.
Product development and support services. Located in Seattle, Washington.
www.designhausinc.com
E
Edaya Inc.
Medical device egineering and market research consulting company; specializes in early stage engineering design, prototyping, and testing and market research for new device concepts.
www.edaya.com
Eisner Safety Consultants
Medical device, in vitro diagnostics and biotechnology regulatory compliance services. Headquartered in Santa Barbara, California.
www.eisnersafety.com
Elite Engineering Corp.
Provider of product development design engineering services, including laser optics, mechanical MEMS, robotics, software and OEM. Concept through manufacturing services are provided. Company is ISO 9001 certified. Services are provided to mul...
www.eliteeng.com
Emergo Group - Medical Device Quality Assurance Consulting
ISO 13485 & FDA GMP consultants for medical devices & IVD. Specialists in international medical device regulations. Offices worldwide. Since 1997.
www.EmergoGroup.com
Emergo Group: Medical Device QA and Regulatory Consultants
Provides consulting for US FDA GMP & ISO 13485 quality systems, FDA 510(k), CE Mark, Japan PAL and China SFDA approval. Offices worldwide since 1997.
www.emergogroup.com
F
Fallbrook Engineering, Inc.
Contract product development, management, and engineering services consulting firm for the healthcare products industry. Located in Valley Center, California.
www.fallbrook-eng.com
MDI Consultants
Worldwide consulting firm specializing in the medical device industry.
www.fdaconsulting.net
Fitch Inc.
An international consulting organization working in partnership with clients to develop new products, new forms of communications and new types of environments. Offices in Boston, London, Columbus, Osaka, Paris, Ann Arbor and San Francisco.
www.fitch.com
I
Interdigit
Provider of sales, marketing and consulting services to medical device companies seeking access to the European market.
www.interdigit-medica.com
International Regulatory Consultants
Specialize in helping manufacturers of medical products coordinate North American, European, and Pacific Rim regulatory affairs and quality systems compliance activities.
www.intregcon.com
L
Labrador Technologies, Inc.
Technical medical resource serving the product development and manufacturing needs of pharmaceutical, medical device, diagnostic and related industries. Headquartered in Chula Vista, California.
www.labradortech.com
M
Mann-Horton & Associates, Inc.
Design consulting firm for technical, consumer, and out-of-the-ordinary products, related graphics, brochures, exhibits, corporate identity programs, and showrooms. Located in New York, New York.
www.mann-horton.com
Medical Device and QA Consultancy
Site offers information about services and related resources.
www.mdqaconsultancy.co.uk
Moto Development Group
Medical product design and engineering. Located in San Francisco, California.
www.moto.com
N
Nachman BioMedical
Provider of search consulting services for the medical and biotechnology industries. Services include medical device, electronics and instrumentation consulting. This company was capitalized by private investment.
www.nachmanbiomedical.com
NAMSA
Provider of non-clinical safety evaluation services for medical devices; and manufacturer of biological indicators used to test for sterility and chemical indicators for monitoring steam sterilizer effectiveness. Products and services are provi...
www.namsa.com
O
Outcomes International
Consulting firm specializing in medical marketing services for the pharmaceutical, biotechnology and medical device industries.
www.outcomesint.com
P
Paladin Medical, Inc.
Provider of biomaterials consulting, pre-clinical in vitro and in vivo protocol design and medical consulting services. The company offers Total Quality System implementation, design control and review procedures, hazard analysis, preclinical a...
www.paladinmedical.com
Q
Al Weisenborn Medical Device Consulting
Regulatory compliance, quality assurance, and manufacturing services for small and medium sized medical device companies.
www.qsrhelp.com
R
AccuReg Bioregulatory & Compliance Associates, Inc.
Technical and regulatory consulting firm serving companies engaged in the development and manufacture of ethical and OTC pharmaceuticals, biological products, medical devices and diagnostics.
www.regulatory.com
Relamatrix Group
Provider of FDA strategic planning, 510(k) preparation, market research and other services related to the medical device industry.
www.relamatrix.com
S
Startup Operations - Medical Device Manufacturing Solutions
Assisting Medical Device and Pharmaceutical companies to implement simple and effective solutions for Operations and Manufacturing related issues.
www.startup-operations.com
STATKING Consulting Inc.
For consulting on statistical methods and data analyses related to clinical trials for new pharmaceutical products and medical devices, product development, regulatory compliance and manufacturing methods. Located in Fairfield, Ohio.
www.statkingconsulting.com
T
Textile Development Associates, Inc.
Technical textile services including consulting and development and products serving the medical devices, vascular grafts, mechanical rubber goods, industrial fabrics, fiber reinforced composites, and filtration markets. Located in Garnerville, ...
www.texdev.com
U
Siemens - Medical Device Consulting
Siemens Healthcare technology helps improve patient outcomes and reduce healthcare cost. Siemens Answers for Healthcare
www.usa.siemens.com/answers
Medical Device Consulting
Quality Regulatory Experts put our expertise to work for you
www.AlvaMed.com
Medical Device Consulting
Consulting, Test and Certification for a wide array of medical devices
www.ntscorp.com
Med. Product Development
Full service engineering & contract manufacturing. Fortune 500 clients.
www.bctechinc.com

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Guide to Medical Device Consulting Education and Training

Open the door to a successful career in medical device consulting

By Harrison Howe


If you're thinking about pursuing a career in medical device consulting, you'll need proper medical device consulting education and training. Whether you'll be working in medical device manufacturing consulting or with medical device marketing consultants, you'll need to learn many aspects of medical equipment consulting.

Fortunately, there are a few ways you can learn to become a medical device consultant. Formal college classes in medical device consulting are a good place to start. Seminars by medical associations or medical device consulting firms also offer extensive training. Finally, looking into internships at medical device consulting companies can be a vital tool in medical device consulting education and training.
  1. Enroll in medical device consulting classes at accredited colleges or universities.
  2. Get into an internship program offered by medical consulting firms.
  3. Sign up for seminars about medical device consulting services.

Action Steps
The best contacts and resources to help you get it done


Look to formal medical device consulting education and training

Though there is no formal degree available to become a medical device consultant, you can find classes addressing medical devices in several programs at a college or university. Some biomedical engineering programs, for instance, include classes on medical devices. In many instances, you can get a certificate in Medical Devices.

I recommend: Ankora-Ramsey Community College offers two medical device certificate programs, Fundamentals and Advanced, with courses taught by professionals in the medical device industry. Enroll in the UNC/NCSU Joint Department of Biomedical Engineering certificate program, given by the University of North Carolina at Chapel Hill and North Carolina State University, to learn medical device project management, design and more.

Intern at medical device consulting firms

Hands-on experience is always a great way to learn in any field, and medical device consulting is no exception. Getting into an internship at a medical device consulting firm can expose you to many aspects of this field, including manufacturing, marketing, engineering and design.

I recommend: For those looking to get into the healthcare field, internships are offered through Harvard Business School, and include many positions at top medical device consulting firms and biotechnology companies. Abbott Laboratories, a manufacturer of surgical and medical devices, offers summer internships in areas such as manufacturing, engineering and quality assurance.

Attend seminars given by medical device consultants

From regulatory issues to marketing, there are many topics covered by seminars conducted by medical consulting firms, medical device marketing consultants, medical device manufacturing consulting firms and others in the medical device field. Intensive seminars should be a major part of your medical device consulting education and training.

I recommend: Medical Device Consultants Inc. (MDCI) offers an annual medical device testing seminar for medical device manufacturing consultants in the field of quality assurance, research and development and design engineering. SPI USA has a two-day training seminar in regulations and quality systems given in collaboration with CardioMed Device Consultants.

FEATURED LISTINGS
Emergo Group - Medical Device Quality Assurance Consulting
ISO 13485 & FDA GMP consultants for medical devices & IVD. Specialists in international medical device regulations. Offices worldwide. Since 1997.
About Emergo | All Services | Japan STED | GMP Consulting
Startup Operations - Medical Device Manufacturing Solutions
Assisting Medical Device and Pharmaceutical companies to implement simple and effective solutions for Operations and Manufacturing related issues.
Siemens - Medical Device Consulting
Siemens Healthcare technology helps improve patient outcomes and reduce healthcare cost. Siemens Answers for Healthcare
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Guide author

Guide to Medical Device Consulting

Get input from medical device consultants for your new product

By Ben Hahn, Freelance Writer


When you're designing and engineering a new medical device, you must make sure your new product complies with a number of regulations. Getting approval for your new product is a necessary part of the process; without it you'll never sell your medical device. Once you've designed a regulation-compliant product, you need to manufacture and market it to the health care organizations that can use it most. Every step of the way, you can use the professional input of medical device consulting firms. Medical device consulting companies offer manufacturing and marketing consulting help, ensuring you create a top notch product that you sell with ease.

Medical consulting firms can be particularly helpful in getting your device approved by the FDA. Search for the medical device consultant that specializes in the part of the process that you need the most advice or help, or find medical device consultants who can provide services every step of the way, from quality assurance to FDA regulation. Some key services that medical device consulting firms can help with include:

1. Obtaining FDA clearance for a medical device.

2. Providing services as an FDA agent to represent your medical device.

3. Responding to a warning from the FDA to get your company back in compliance.


Action Steps
The best contacts and resources to help you get it done


Design your product with the help of a medical device consulting firm

The creative process can be the most exciting part of product development, but can also be the most frustrating. Get expert help form a medical device consultant in designing your new medical device, and also ensure that your product fits regulatory standards.

I recommend: Elite Engineering Corporation promises fast turnaround for prototypes of your product and marketing models so you can sell your device. Edaya is a medical device consulting company that uses 3D CAD software for rapid prototyping of your product. They can also create animations and 3D models to help market your device.

Obtain and maintain regulatory compliance

Your medical device must be approved by the FDA for sale, so you want to be sure you're complying with all necessary regulations, a process medical device consultants can help you with. If you do happen to get in trouble with the FDA, medical consulting firms can also represent your case for compliance.

I recommend: Emergo Group can help you with all of your medical device regulatory needs. They also provide quality assurance services.

Market and sell your medical device

Once you've designed and manufactured your product, medical device marketing consultants will help you sell your new product to the health care industry.

I recommend: Relamatrix will conduct market research and analytical studies, as well as help you with advertisements and media placement.

Tips & Tactics

Helpful advice for making the most of this Guide

  • •  If you head a health care organization that has purchased a new medical device, many medical device consulting firms offer instrumentation consulting as well as design. Use their services to help your employees start using your new product in the most knowledgable and efficient way.

FEATURED LISTINGS
Emergo Group - Medical Device Quality Assurance Consulting
ISO 13485 & FDA GMP consultants for medical devices & IVD. Specialists in international medical device regulations. Offices worldwide. Since 1997.
About Emergo | All Services | Japan STED | GMP Consulting
Startup Operations - Medical Device Manufacturing Solutions
Assisting Medical Device and Pharmaceutical companies to implement simple and effective solutions for Operations and Manufacturing related issues.
Siemens - Medical Device Consulting
Siemens Healthcare technology helps improve patient outcomes and reduce healthcare cost. Siemens Answers for Healthcare
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Guide to Medical Device Consulting Key Terms

Some key terms for how medical device consulting firms help device planning businesses

By J. Stoltzfus, writer/programmer, LOCAL CITIZEN


When a business wants to make and distribute medical devices, medical device consulting is a valued service. Medical device consulting firms act as partners with businesses that are planning to compete in the medical device consulting market. A good medical device consulting firm can be the ticket to sales, and the difference between hassles and red tape from regulatory agencies and a viable market product. Reading up on these basic key terms for medical device consulting can show how this often works.

Action Steps
The best contacts and resources to help you get it done


FDA regulations for medical devices

Medical device consulting firms often have to help businesses in creating medical devices that are compliant with FDA regulations. The FDA or Food and Drug Administration is the agency tasked with regulating medical devices, and they have proprietary standards for compliance.

I recommend: Get a whole lot of details on FDA regulations for medical devices at this FDA page.

FDA agent

A medical device consulting firm can also act as an 'FDA agent' for a client, going to bat as a representative before the FDA to get medical device plans passed through for manufacturing and sale.

I recommend: See an example of a medical device consulting firm acting as an "FDA agent" for clients at this page from Emergo Group.

JCAHO medical equipment standards

JCAHO is the Joint Commission on Accreditation of Healthcare Organizations and has jurisdiction over hospitals and similar facilities. JCAHO has established some regulations for medical devices that medical device consultants might help with.

I recommend: See more on medical device consulting and JCAHO at this page from 24x7.

Prototypes

Prototypes are 'models' or drafts of later results. Medical device consulting firms can help businesses establish prototypes that will reveal a lot about how a medical device will be made and put on the market.

I recommend: See the definition of prototypes at the Free Dictionary.

Computer Aided Design

Computer Aided Design or CAD is the process of using 3D software to model physical items. Medical device consulting firms can also help use CAD to model prototypes for in-depth analysis before production starts.

I recommend: See more on Computer Aided Design for medical device manufacturers at Device Link.

Market research

Market research is the process of collecting data about the business that a company is in to make good decisions based on existing or projected supply and demand. Medical device consulting firms can help with market research as well as other aspects of selling medical devices.

I recommend: See more on market research at WiseGeek.

FEATURED LISTINGS
Emergo Group - Medical Device Quality Assurance Consulting
ISO 13485 & FDA GMP consultants for medical devices & IVD. Specialists in international medical device regulations. Offices worldwide. Since 1997.
About Emergo | All Services | Japan STED | GMP Consulting
Startup Operations - Medical Device Manufacturing Solutions
Assisting Medical Device and Pharmaceutical companies to implement simple and effective solutions for Operations and Manufacturing related issues.
Siemens - Medical Device Consulting
Siemens Healthcare technology helps improve patient outcomes and reduce healthcare cost. Siemens Answers for Healthcare
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Medical Device Consulting Education and Training

Open the door to a successful career in medical device consulting.
If you're thinking about pursuing a career in medical device consulting, you'll need proper medical device consulting education and training. Whether you'll be working in medical device manufacturing consulting or with medical device marketing consultants, you'll need to learn many aspects of medical equipment consulting.Fortunately, there are a few ways you can learn to become a medical device consultant ... Read more

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