Bob Helton - President

Bob has been working in nuclear medicine for over 30 years.  Originally with the R&D group at Medical Data Systems. Teaching mathematics and computer science at Northern Michigan University.  Founding MedImage in 1985 developing imaging and communications products for nuclear medicine.  Becoming President of MedImage in 1991.

 


Randy Pratt - Customer Support Manager

Randy Pratt is the Customer Support Manager at Medimage.  He received his certification in Radiology Technology from Providence Hospital in Southfield Michigan, and certification in Nuclear Medicine Technology from William Beaumont Hospital in Royal Oak, Michigan. After working as a Radiology &
Nuclear Medicine Technologist, progressing to Assistant Radiology Manager, Randy decided it was time for a change, and became an Application Specialist at MedImage. After a time as a Field Service Engineer with Sterling Diagnostic Imaging,  Randy finally returned to MedImage as the Customer Support Manager.


Tod Henderstein - Sales Manager

Classically trained as a nuclear medicine technologist, Tod worked in the hospital setting before moving into the private sector first as an application specialist and then a systems consultant for ADAC Labs (now part of Philips).   Working at Siemens Medical Systems, Tod sold some of the first PET systems for clinical use in the US.  In his over twenty years at MedImage, Tod has seen many changes to the products and markets, like the introduction of remote reading and PET/CT.  In his leisure time, Tod likes to play golf, go snow skiing and ride his bike as far as he can.

 

QUALITY POLICY

MedImage, Inc. is committed to ensuring the quality and usefulness of our products by continually evaluating and improving our business processes included in our quality management system by maintaining compliance with the FDA-QSR 21 part 820 and ISO 13485 regulatory standards.  Constantly improving the way we develop, manufacture and support our products, enables us to produce medical imaging software that meets and strives to surpass our customers’ expectations, and keep us at the forefront of technology. 

PRODUCT CLASSIFICATION
Classification rules differ between the United States and the European Union; therefore, the following defines the classification for the DELTAmanager Product Line.

US FDA - The DELTAmanager Product Line classification falls under FDA 21CFR892.1200 as a Class II - Radiological Diagnostic Device.  As stated in Part 892 Radiology Devices: Subpart B section 892.2050 Diagnostic Devices.

US FDA Good Manufacturing Practice (GMP) - We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. View our Establishment Registration on the FDA website

Europe - The DELTAmanager Product Line falls under the MDD93/42/EEC Council Directive classification from Annex IX Sec. III.-Classification/ sec. 3.3 - Rule 12 as a Class 1 medical device. This route of compliance is directed from Annex VII of the MDD93/42/EEC Council Directive.

 

QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification ISO 13485:2016 certificate #C0067085-MD6

Authorized Representatives
MedImage Inc. Authorized Representative(s) are:

China - 

Becquerel & Sievert Co. Ltd.
Room 2004, No. 555, Pudong Ave.
Pudong District
Shanghai, China   200122

Europe - 

Emergo Europe
Pinsessegracht 20
2514 AP
The Hague, Netherlands
www.emergogroup.com

Certification Body
MedImage, inc. maintains ISO 13485 certification and is audited yearly by:

NSF- International Strategic Registrations
789 North Dixboro Road
Ann Arbor, MI 48105
www.nsf-isr.org


PRODUCT CERTIFICATIONS AND APPROVALS
Taiwan - TFDA license number DHA05602611601