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
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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
Save
My Rating
Medical Device Consulting
Regulatory & Clinical Specialists Offices in UK and Netherlands
www.mediqol.com
Regulatory & Clinical Specialists Offices in UK and Netherlands
www.mediqol.com
Medical Device Expertise
AlvaMed: Experts in QA RA R&D IP PM Put Our Expertise to Work for You
www.AlvaMed.com
AlvaMed: Experts in QA RA R&D IP PM Put Our Expertise to Work for You
www.AlvaMed.com
Reimbursement Consultants
Actionable Reimbursement Solutions For Medical & Biotech Companies
www.argentaadvisors.com
Actionable Reimbursement Solutions For Medical & Biotech Companies
www.argentaadvisors.com
Medical Device Consulting
Experienced financial and marketing consulting in medical technology
www.EssHcc.com
Experienced financial and marketing consulting in medical technology
www.EssHcc.com
Medical Equipment Repair
Hospitals, Surgery Centers, etc Fresno, California
www.multimedicalsystems.com
Hospitals, Surgery Centers, etc Fresno, California
www.multimedicalsystems.com
Pharma Consultants
Fastest growing database of regulatory consultants Worldwide
www.PharmalinkConsulting.com
Fastest growing database of regulatory consultants Worldwide
www.PharmalinkConsulting.com
Listings
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
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
Bridge Product Design
Product design and engineering consultancy for the consumer and medical markets, using CAD technology.
www.bridgedesign.com
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
Engineering biotech, medical, and plastic products. Located in Oakland, California.
www.burdconsulting.com
Curt Deckert Associates, Inc.
R&D consultants specializing in optics, light and imaging technologies.
www.cdeckert.com
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
Consulting in product engineering, manufacturing, and quality systems for disposable medical devices.
www.clarkgroup.net
Computer Solutions Integrators & Products
Helps biomedical device manufacturers and others develop innovative test engineering solutions. Located in Woodbury, Minnesota.
www.computersolutions.com
Helps biomedical device manufacturers and others develop innovative test engineering solutions. Located in Woodbury, Minnesota.
www.computersolutions.com
Crestway Corp.
Consulting and design services for medical camera projects. Located in Titusville, Florida.
www.crestway.com
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
Consulting in product and process development for medical device and in vitro diagnostic manufacturers and start-ups.
www.crispinfo.com
Designhaus, Inc.
Product development and support services. Located in Seattle, Washington.
www.designhausinc.com
Product development and support services. Located in Seattle, Washington.
www.designhausinc.com
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
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
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
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.
About Emergo | All Services | Japan STED | GMP Consulting
www.EmergoGroup.com (Paid)
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 (Paid)
Emergo Group: Medical Device QA and Regulatory Consultants
Provides consulting for FDA GMP & ISO 13485 quality systems, FDA 510(k), CE Mark, Japan PAL and China SFDA approval. Offices worldwide since 1997.
www.emergogroup.com(Paid)
Provides consulting for FDA GMP & ISO 13485 quality systems, FDA 510(k), CE Mark, Japan PAL and China SFDA approval. Offices worldwide since 1997.
www.emergogroup.com(Paid)
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
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
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
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
Interdigit
Provider of sales, marketing and consulting services to medical device companies seeking access to the European market.
www.interdigit-medica.com
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
Specialize in helping manufacturers of medical products coordinate North American, European, and Pacific Rim regulatory affairs and quality systems compliance activities.
www.intregcon.com
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
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
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
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
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
Medical product design and engineering. Located in San Francisco, California.
www.moto.com
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
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
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
Outcomes International
Consulting firm specializing in medical marketing services for the pharmaceutical, biotechnology and medical device industries.
www.outcomesint.com
Consulting firm specializing in medical marketing services for the pharmaceutical, biotechnology and medical device industries.
www.outcomesint.com
Pacific Consultants, LLC
Product evaluation consulting, patentability consulting and expert witness consulting. Located in Mountain View, California.
www.pacificconsultants.com
Product evaluation consulting, patentability consulting and expert witness consulting. Located in Mountain View, California.
www.pacificconsultants.com
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
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
Al Weisenborn Medical Device Consulting
Regulatory compliance, quality assurance, and manufacturing services for small and medium sized medical device companies.
www.qsrhelp.com
Regulatory compliance, quality assurance, and manufacturing services for small and medium sized medical device companies.
www.qsrhelp.com
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
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
Provider of FDA strategic planning, 510(k) preparation, market research and other services related to the medical device industry.
www.relamatrix.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
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
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
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
Medical Device Consulting
Regulatory & Clinical Specialists Offices in UK and Netherlands
www.mediqol.com
Regulatory & Clinical Specialists Offices in UK and Netherlands
www.mediqol.com
Medical Device Expertise
AlvaMed: Experts in QA RA R&D IP PM Put Our Expertise to Work for You
www.AlvaMed.com
AlvaMed: Experts in QA RA R&D IP PM Put Our Expertise to Work for You
www.AlvaMed.com
Guide to Medical Device Consulting
Get input from medical device consultants for your new product
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.
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.
