BMDK Business Accelerator
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The BMDK business accelerator is an exciting opportunity for young companies with the following attributes:
  • Product
  • Process or service that is manufacturable and marketable
  • Team in place to fulfill your requirements, or work with us so you can focus on development
  • Sufficient capital to rent space in our facility
  • Intent to establish a quality management system under the BMDK umbrella
At its core, BMDK started as a one-stop-shop for biomedical device design, manufacturing, and production.

Over the years, our scope has expanded and we now provide a full-service business accelerator for companies in the device and pharmaceutical spaces as well as traditional fixed fee-for-service activities.

We collaborate with universities, start-ups, physicians, entrepreneurs and independent innovators in joint research projects.

BMDK is an FDA-registered and ISO-certified to Annex II.

BMDK offers all of the major disciplines needed to develop and commercialize your process or medical device including:

  • Regulatory Services including labeling, 510(k) and PMA submissions, and applications for CE Mark.
  • Licensable Quality Management System
  • Design Engineering
  • Prototype development including electrical and mechanical medical devices, software and pharmaceuticals
  • For our business accelerator customers, a legal presence in the state of Kansas will be required and you will receive a customized quality management system that will allow you (or us) to design, develop and manufacture your product(s) in full compliance with FDA and ISO regulations.

If your product or process requires outside help, we have formal relationships with a number of universities and university systems in both the Midwest and in Asia and can bring the research and academic solutions to your problem through our exclusive partnerships.

Regulatory Capabilities

Being in the medical device business we fully understand the challenges posed by FDA, ISO and other regulatory authorities. The challenges are not only limited to the complex regulatory laws, but also involve the cost of hiring consultants.

BMDK is committed to provide other medical device companies with the best regulatory and compliance services at competitive price.

We are an ISO 13485 certified company

 Our Services include:

  • Risk Assessment
  • Quality System Regulation
  • Design Controls
  • Validation
  • Project Management Capabilities
  • Gap Analysis
  • Preparation of FDA Registration and Listing
  • Assistance with Regulatory Strategies and Assessment
  • Liaison with FDA for Pre-submission or Special Meetings
  • 510(k), Investigational Device Exemption (IDE), Pre-Market Approval (PMA) Preparation and/or Assistance
  • FMEA's
  • Report and Summary Preparation
  • Protocol Development
  • Assistance with FDA’s Good Manufacturing Practices (GMP) set forth in the Quality System (QS) regulation
  • Post-market surveillance and address complaint handling-including MDRs (Medical Device Reports) and device tracking
  • FDA pre- IDE and IDE support

Contact us now to find out how we can help you

Regulatory Services

Since BMDK's inception in 2006, we have continually improved and increased the scope of our regulatory activities. You can now count on us to provide not only submissions such as technical file and 510(k)'s, CE Mark Technical Files & Design Dossiers, PMA's, etc., but also look to us for FMEAs, risk mitigation and risk reduction analyses, gap analyses, etc.

Our quality management system (QMS) stays on top of all relevant FDA guidance documents and industry regulation, as well as regulations by other governing bodies and authorities such as OSHA, EPA, etc. When new guidance documents and regulations are issued, our QMS is updated and our customers are notified of the impending changes so that they can affect timely and cost-effective responses.

If you have a legal presence at BMDK, your inspections most likely will take place at our facility. Our in-house experts will be there with you to aid in this process.

If your product requires testing to an outside standard, BMDK can work with you to have this outside testing performed.