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Proven Process

NextPhase Medical Devices acquires Proven Process Medical Devices

May 25, 2021 By Chris Newmarker

NextPhase Medical Devices and Proven Process Medical Devices are merging — another example of ongoing medtech contract manufacturing consolidation. The financial terms of the deal were not disclosed in today’s announcement. Get the full story on our sister site Medical Design & Outsourcing. 

Filed Under: Business/Financial News, Contract Manufacturing, Mergers & Acquisitions Tagged With: NextPhase Medical Devices, Proven Process, Proven Process Medical Devices

M2M Communication Considerations in Medical Device Development

August 2, 2018 By MassDevice

Machine-to-machine communication (M2M) refers to the sharing of information between two devices. It is a key component in the rapidly growing “Internet of Things” (IoT), the increasing connectivity of devices in the home, workspaces, industry, and beyond. M2M communication can be as simple as the unidirectional transfer of data or as complex as multiplexed signals […]

Filed Under: Whitepapers Tagged With: Proven Process

What You Need to Know About the ISO 13485:2016 Update

May 21, 2018 By MassDevice

ISO 13485:2016: An Introduction The international standard ISO 13485 governs the manufacture of medical devices. The first edition was published by the International Organization for Standardization (ISO) in 1996. The ISO currently reviews standards at least every five years to determine whether they need to be updated. The first update to ISO 13485 was released […]

Filed Under: Whitepapers Tagged With: Proven Process

LVAD Efficiency and the Criticality of Accurate Blood Pressure Measurement

April 18, 2018 By MassDevice

What is a LVAD? How does it work? A left ventricular assist device (LVAD), also called a ventricular assist system or VAS, is a mechanical pump that is attached to the left ventricle of the heart to augment the function of the heart’s main pumping chamber. The left ventricle pumps blood from the heart to […]

Filed Under: Whitepapers Tagged With: Proven Process

The Case for Real-World Evidence (RWE) in Medical Device Development

November 30, 2017 By MassDevice

Medical Devices are used in the real world every day, so shouldn’t they be tested in the real world? You would think so. But the FDA hasn’t necessarily been of that mindset — until now. Per FDA regulations, testing has to be conducted under supervised clinical trials, which have pre-designed protocols. When most think of […]

Filed Under: Whitepapers Tagged With: Proven Process

GI Dynamics taps Proven Process as EndoBarrier manufacturer

July 26, 2017 By Fink Densford

GI Dynamics (ASX:GID) said today it inked a contract manufacturing partnership deal with Proven Process Medical Devices. Through the deal, Proven Process will manufacture Boston-based GI Dynamic’s EndoBarrier device at its Mansfield, Mass.-based facilities. Read the whole story on our sister site, Medical Design & Outsourcing

Filed Under: Business/Financial News Tagged With: GI Dynamics, Proven Process

Proven Process, Innoblative Designs partner for novel ablation device

February 9, 2016 By Fink Densford

Proven Process Medical Devices said today it was selected by novel ablation developer Innoblative Designs to act as a partner to develop and manufacture their ablation device. Innoblative, originally incubated at Northwestern University’s Center for Device Development, is developing the device to allow operating physicians to ablate surgical margins post excision. “Innoblative’s impressive early-stage success […]

Filed Under: Business/Financial News, Catheters Tagged With: Innoblative Designs, Proven Process

Proven Process to develop cell implant device for Giner

November 18, 2015 By Fink Densford

Proven Process Medical Devices said yesterday it signed on to develop and manufacture a cell implant device for Giner used to administer cell therapies for indications such as liver failure, Parkinson’s disease, parathyroid disease, pancreatectomy and Type 1 diabetes. Giner is developing a miniaturized implantable electrochemical oxygen generator to continuously supply oxygen to islets or cells […]

Filed Under: Business/Financial News, Contract Manufacturing, Diabetes Tagged With: Giner, Proven Process

Proven Process, PathMaker Neurosystems ink deal for neurostim device

June 18, 2015 By Fink Densford

Proven Process said today that it’s partnering with PathMaker Neurosystems, a clinical-stage neuromodulation company, to develop and manufacture a device for treating patients with muscle tone disorders using trans-spinal direct current stimulation. Trans-spinal direct current stimulation is a novel form of non-invasive neurostim, Mansfield, Mass.-based Proven Process said. The spinal stimulation uses a direct current to stimulate […]

Filed Under: Business/Financial News, Neuromodulation/Neurostimulation, Pain Management Tagged With: PathMaker Neurosystems Inc., Proven Process

Proven Process client Flowonix Medical Inc. achieves FDA PMA Approval of Prometra II infusion device

June 5, 2015 By MassDevice

MANSFIELD, MA – Proven Process Medical Devices, Inc., a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, announced today that its client Flowonix Medical Inc. has secured PMA-Supplemental approval from the FDA for its next-generation intrathecal infusion device, the Prometra® II system. Approval of this device, […]

Filed Under: News Well Tagged With: Press Release, Proven Process

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