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MDR/IVDR Consultants

  • 1.  MDR/IVDR Consultants

    Posted 24-Jan-2018 15:19

    I am compiling a list of MDR/IVDR Consultants.  Does anyone have experience and/or make a recommendation?

     

    Whitney Davis

    Global Regulatory Affairs Specialist

    Laboratory Products Division

     

    Thermo Fisher Scientific

    401 Millcreek Road | Marietta, OH  45750

    Tel: +1 (740) - 568-5798 | Mobile: +1 (304) 893-4442 | Fax: +1 (740) -376-2879

    whitney.davis@thermofisher.com | www.thermofisher.com

     

     

     

    "The World Leader In Serving Science"

    www.thermofisher.com

     



  • 2.  RE: MDR/IVDR Consultants

    Posted 25-Jan-2018 08:53
    ​I don't even know any "MDD" consultants, and I've consulted on the MDD on and off since the late 90s.  My expertise is primarily in product certification, design dossiers, clinical evaluations, and event reporting.  I leave, for example, MDD QMS to the MDD QMS consultants.

    If you are just trying to compile a database of MDR/IVDR consultants, regardless of what part if the regulations they have experience with, to be then be sorted through and be readily available for later consultation, as the need arises, I think that's a very wise thing to be doing right now.  However, if you have something more specific in mind, some clarification would probably be helpful.

    Right now it seems that the majority of MDR/IVDR that's going on is assistance with gap analyses, because the majority of companies interested in the new regulations already have devices on the market under the old regulations.  Since I work mostly with startups trying to get their devices on the market for the first time ever, I'm not involved in that.  But I'm sure there are a number of other consultants in the forum who are already hard at work in this area.

    PS  It is also useful to keep in mind that, from a true consulting (as opposed to contracting) perspective, there are no MDR/IVDR experts right now...not even in Brussels, nor at the CAs, nor the NBs, I'd argue.  All anyone knows so far is what the new regulations SAY, and that's seldom the expertise that is most critically needed when it comes time to engage in a regulated activity.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: MDR/IVDR Consultants

    Posted 25-Jan-2018 11:14
    ​As one of the inaugural 22 individuals in the world to receive the EU RAC designation back in 2001 followed by continuing recertification thereafter, I'd like to add my name to your list.  I can also recommend Dan O'Leary.  In addition, I also saw today an impressive Forum post addressing European compliance by Roger Gray at Donawa Lifescience Consulting.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------

    Original Message


  • 4.  RE: MDR/IVDR Consultants

    Posted 25-Jan-2018 17:33
    Dear W:

    Please include me under your category of "EU Consultants" who are ready, willing and able to fight for you while dealing with NBs and interpretation of regulatory requirements in EU.

    Of course, not emotionally but on a documented justifiable basis!

    ------------------------------
    Dr. David Lim, Ph.D., RAC, ASQ-CQA
    REGULATORY DOCTOR
    http://www.RegulatoryDoctor.US
    Phone (Toll-Free): 1-(800) 321-8567
    E-mail: David@RegulatoryDoctor.US
    ------------------------------

    Original Message


  • 5.  RE: MDR/IVDR Consultants

    Posted 26-Jan-2018 06:45
    Interesting debate, and although I might agree with Julie that at this moment nobody would have all the answers during the development of the interpretation of the legal text, I would presume in the land of the blind, still one eye is king....

    Having been involve with writing and negotiating the text of both MDR and IVDR since 2007, and still being heavily involved in debates around the slowly growing interpretations, I'd be happy to get involve in your MDR and IVDR implementation processes and key strategic discussions. Not coming alone, but with a good team that I would happy call for now MDR and IVDR implementation experts..... Check them out on the Qserve group website, or get in touch at Gert.Bos@qservegroup.com




    ------------------------------
    Gert Bos FRAPS, PhD
    Executive Director & Partner
    Qserve Group Inc. - ENTERPRISE
    Baarn
    Netherlands
    Gert.bos@qservegroup.com
    ------------------------------

    Original Message


  • 6.  RE: MDR/IVDR Consultants

    Posted 26-Jan-2018 06:57
    While I typically focus on US submissions due to my FDA background, I know that Network Partners is putting together a team of consultants and contractors to help companies with MDR updates and the required CERs.

    ------------------------------
    Michael Nilo
    Network Regulatory Partners
    Portland OR
    United States
    ------------------------------

    Original Message


  • 7.  RE: MDR/IVDR Consultants

    Posted 26-Jan-2018 08:38
    Hi Whitney!

    I am a consultant for Regulatory and Quality Solutions LLC (R&Q) and we provide regulatory and quality consulting and engineering to medical device companies.  Below is a link to our website which provides more information on who we are and the services we provide.

    Regulatory and Quality Solutions (R&Q) | Medical Device Consultants

    If you have additional questions, please don't hesitate to reach out.  I can also send your inquiry to your Client Solutions partner.

    Have a great Friday!

    Felicia

    ------------------------------
    Felicia Hosey, RAC
    Principal Specialist
    Regulatory & Quality Solutions, LLC
    http://rqteam.com
    ------------------------------

    Original Message


  • 8.  RE: MDR/IVDR Consultants

    Posted 27-Jan-2018 04:21
    Hi Whitney,
    I am Senior Consultant for Vantage Consulting International. Each of our consultants have over 20 years experience in the medical device and pharmaceutical industries. We specialize in Quality System Development, Regulatory compliance and submissions (both US FDA, and ROW), Seminars and Training, and Project Management. 

    Please add us to your list. Our website is Vantage International: Pharmaceutical & Medical Device Consultants

    Best regards,
    Helen Chandler, ASQ CQE, RAC (lapsed)

    ------------------------------
    Helen Chandler
    Sr. Consultant
    Chapel Hill NC
    United States
    ------------------------------

    Original Message


  • 9.  RE: MDR/IVDR Consultants

    Posted 29-Jan-2018 09:42

    Whitney,

    For anyone who needs assistance in digital health (which can be regulated as a device) and combination products (device/small molecule or large molecule), my firm, Hughes Biopharma Advisers, has consultants with 20 plus years of experience. We have worked on FDA and global submissions, quality & compliance (including internal and external audits), due diligence for alliances & partnering and messaging for marketing. We have created our own digital health tool so have hands-on experience.

    Our website is http://hughesbiopharma.com 

    hughesbiopharma.com
    Hughes BioPharma Advisers is a boutique consulting firm focused on biotech, pharmaceutical and healthcare investor consulting with unique digital and mobile health ...


    Please include us in your list.


    Kind Regards,

    Candice


    Candice M. Hughes, PhD, MBA

    CEO/Founder

    Hughes BioPharma Advisers LLC

    New York City metro (Darien, CT)

    203-656-3045

    http://hughesbiopharma.com

    http://linkedin.com/in/candicemhughes





    Original Message


  • 10.  RE: MDR/IVDR Consultants

    Posted 28-Jan-2018 17:05
    Dear Whitney,

    concerning EUMDR, please contact me.

    Regards

    Peter




    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------

    Original Message


  • 11.  RE: MDR/IVDR Consultants

    Posted 28-Jan-2018 18:30
    Hello Whitney

    SQR Consulting provides regulatory affairs consulting services to medical device manufacturers. We have more than 16 years of experience in medical device regulations, CE Marking in particular, and also have a strong participation in international standards development. 

    ------------------------------
    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo
    Brazil
    ------------------------------

    Original Message


  • 12.  RE: MDR/IVDR Consultants

    Posted 29-Jan-2018 09:20
    Dear Whitney, 
    I have been a consultant for the medical device industry for over 16 years and have helped many companies, including Thermo Fisher  in successfully implementing standards and regulations.  Please add me to your list.

    ------------------------------
    Angela Nunez RAC, CQA, ex-CQE
    Quality Assurance/Compliance
    ainunez@comcast.net
    (954) 643-8598
    Pembroke Pines, FL
    ------------------------------

    Original Message


  • 13.  RE: MDR/IVDR Consultants

    Posted 29-Jan-2018 09:50

    Hello Whitney,

    Our in-house regulatory team works very closely and currently with MDR/IVDR requirements.  We also actively participate in the working groups as well.  I would be pleased to introduce our VP to you.

    My direct email: jmarkham@clinlogix.com  

    Kindest regards,
    JeanMarie



    ------------------------------
    JeanMarie Markham
    CEO
    Clinlogix
    jmarkham@clinlogix.com
    Tel: (215) 855-9054 x7001
    ------------------------------

    Original Message


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