EU MDR Whitepaper: Quality Management Systems
The MDR contains explicit requirements for manufacturers to establish, implement, and manage a quality management system (QMS).
read moreMedical Information: A Patient’s Case Study
The What, Why, and How of Medical Information In a recent Q1 Productions survey, patients and caregivers shared their thoughts about medical and disease information. The preferred vehicles of information, trusted sources, and unaddressed needs were answered by...
read moreNew Medical Devices Regulation and IVD Regulation Now Published
After more than five years of debate, negotiation and consultation, the new European Medical Device Regulation was published in the Official Journal of the European Union on May 5, 2017, including formal implementation and compliance mandates.
read moreWill 2018 be Pharma’s Greatest Year Yet?
Will 2018 be Pharma’s Greatest Year Yet? The pharmaceutical industry has faced many changes in 2017. Legislative uncertainty, patient-centricity, and ransomware threats are just a few of the industry’s hurdles so far. Looking ahead, however, the industry may be...
read moreForecasting Legislation and Industry Changes in the Trump Administration
Forecasting Legislation and Industry Changes in the Trump Administration With the recent passing of the American Health Care Act (AHCA) through the U.S. House of Representatives, many industry leaders are anticipating the possible changes the AHCA may bring....
read moreMichael Narachi – Orexigen Therapeutics, Inc.
8th Annual Life Science CEO Forum: Speaker Interview
read moreDoreen Taylor – Haemonetics
6th Semi-Annual Medical Device Supplier Quality Conference: Speaker Interview
read moreJoerg Pantermoller – Biotronik
5th Semi-Annual Medical Device Supplier Quality Conference Speaker Interview:
read moreErica Smith – Cisco
Executive Leadership Support Forum: Atlanta: Speaker Interview
read moreEric Steen – InfuSystem Holdings, Inc.
8th Annual Life Science Chief Executive Officer Forum: Speaker Interview
read moreMyomo Gains EU Approval for Wearable Motion Brace
Myomo has announced that its wearable device, MyPro, has gained approval for launch in the European Union. The device functions as a lightweight brace with enables patients who have suffered a stroke or spinal cord injury to resume movement in weakened...
read moreSenate Votes in Favor of AHCA Consideration
Early today senators met to vote on a procedure dubbed “Vote-A-Rama” in which various parts of the House GOP bill, which passed house majority in May, before being sent first to the House and then to the President for approval. If approved, this bill would...
read moreGOP Face New Healthcare Hurdles after No Healthcare Vote
Following the arrival and opposition to the GOP’s latest healthcare bill, the Better Care Reconciliation Act of 2017, republican lawmakers have begun to re-examine future healthcare possibilities. The healthcare battle began in March with the introduction of the...
read moreNovartis Seeks Approval for New Cancer Therapy
Novartis has submitted an approval application for its CART-T cell therapy to the FDA. The therapy, which has not yet been approved for any company by the agency, is targeted towards children and young adults suffering from Leukemia. In this new immunotherapy...
read moreCONTACT US
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