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Qosina Announces Scott Herskovitz as New
President & CEO
Ronkonkoma, NY,USA,January 3, 2018—Qosina Corp. is pleased to
announce the appointment of Scott Herskovitz to president and chief executive
officer, effective immediately. As president and CEO, Scott will have
responsibility for development and execution of the company’s strategic plan.
“I am very excited about the future of Qosina and look
forward to continued positive growth under Scott’s leadership,” said Qosina
Chairman of the Board Stuart Herskovitz. “Scott’s experience, strategic thinking
and proven ability to deliver results make him the perfect person for this role.
His vision and communication style will bring a new level of engagement and
performance from the employees. I enthusiastically welcome Scott as Qosina’s new
leader.”
Prior to his promotion topresident and CEO, Scott worked in
business development, served as vice president of marketing, and later, vice
president of sales and marketing at Qosina. “I am thrilled and honored to take
on the role of president and CEO of Qosina,” said Scott Herskovitz. “Stuart
Herskovitz had a vision 38 years ago of what he wanted the Qosina brand to be.
He worked hard to build the company into the global powerhouse that it is today
and a trusted partner to our customers, distributors and vendors. Stuart is a
leader of great integrity, character and intellect. I look forward to building
on the Qosina foundation and taking the company to the next level by helping our
customers find, order and receive quality medical components quickly and
accurately.”
Founded in 1980, Qosina is a leading global supplier of OEM
single-use components to the medical and pharmaceutical industries. Qosina’s
philosophy is to address its customers’ need to reduce time-to-market by
providing thousands of stock components. The company’s vast catalog features
more than 5,000 products shown in full-scale illustrations on a onecentimeter
grid. Qosina offers free samples of most items, low minimum order requirements,
just-in-time delivery, modification of existing molds, and new product design
and development. Qosina isISO 9001, ISO 13485 and ISO 14001 registered, and
operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. visit
www.qosina.com or call +1 (631) 242-3000.
Contact : Qosina Corporation, Rachelle Morrow
+1 (631) 242-3000, rmorrow@qosina.com.
DCGI Issues Classification Of Medical
Devices & In Vitro Diagnostics
The Drugs Controller General of India (DCGI) has issued
classification of medical devices and in vitro diagnostic medical devices under
the provisions of the Medical Devices Rules, 2017.
These Rules will be applicable to substances used for in
vitro diagnosis and surgical dressings, surgical bandages, surgical staples,
surgical sutures, ligatures, blood and blood component collection bag with or
without anticoagulant covered under subclause (i); substances including
mechanical contraceptives (condoms, intrauterine devices, tubal rings),
disinfectants and insecticides notified under sub-clause (ii); and devices
notified from time to time under sub-clause (iv), of clause (b) of section 3 of
the Drugs and Cosmetics Act, 1940 (23 of 1940).
As per the Rules, medical devices other than in vitro
diagnostic medical devices will be classified on the basis of parameters
specified in part I of the first schedule, namely low risk as Class A; low to
moderate risk as Class B; moderate to high risk as Class C; and high risk as
Class D. In vitro diagnostic medical devices will be classified on the basis of
parameters specified in part II of the First Schedule, namely low risk as Class
A; low to moderate risk as Class B; moderate to high risk as Class C; and high
risk as Class D.
Safety, quality and performance of medical devices are
regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules
made thereunder. In this connection, in exercise of the powers conferred under
sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the DCGI has classified
the medical devices and in vitro diagnostic medical devices, based on the
intended use of the device, risk associated with the device and other parameters
specified in the First Schedule.
As per the classification issued by the DCGI, Radiofrequency
Ablation Device, Percutaneous Conduction Tissue Ablation, Coronary stent,
Bioresorbable Vascular Scaffold (BVS) System, Angiographic Guide Wire, Cardiac
Catherization Kit, Balloon for Cerebrovascular Occlusion, Intra-Aortic System
Balloon and Control, RETRIEVAL SNARE, Cardiac Thermodilution Catheter,
Cardiovascular Catheter, Cerebrospinal Catheter, Atherectomy coronary Catheter,
to name only a few, have been listed in the high risk Class D category.
Vein Ablation device, Thermal Ablation device, Uterine
balloon therapy devices, RF Conducte MR steerable electrode catheter, Bone
cement, Bifurcation Stent, Vena Cava Filter Sets, Central Venous Catheters,
Introducer Sheath, Carotid Filter System, Hemodialysis Catheter (Long Term),
Percuataneous Intravascular Long Term Catheter, Implanted Subcutaneous
Intravascular Port & Catheter, Subcutaneous Intraspinal Port & Catheter,
Coronary Dilation Catheter, Diagnostic Radiology Catheters, Micro-catheter,
Tympanostomy Tube, Anastomosis Bypass Tube, etc have been listed in the moderate
to high risk Class C category.
Fiberoptic Oximeter Catheter, A-V Shunt or Fistula Adapter,
Forceps endoscopic, Vessel Dialator for percutaneous Catheterization,
Tracheobronchial Suction Catheter, Cervical Drain, Rectal Balloon, Vial
Adapter, Nasopharyngeal Catheter/ Nasophar yngeal, Esophageal obturator, Suction
Tip and Catheter, Arterial Catheter, Cholangiography Catheter, Umblical Artery
Catheter, Flow Directed Catheter, Endoscopic Ligation Devices, Dialysate Tubing
and Connector, Colon Tube, Connecting Tube, Decompression Tube, Biopsy Needle
Kit, Mammary Biopsy Needle, Cholangiography Needle, Epidural Needle, etc have
been included in the Class B category.
Nasopharyngeal Catheter/Nasophar yngeal, Y-Connector as an
accessory to perfusion sets, Surgical Dressings, Umbilical occlusion device,
Bolster Suture, Alcohol Swabs, etc have been included in the Class A category.
(Ref: http://www.pharmabiz.com NewsDetails.aspx?aid=105268&sid=1)
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