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TÜV
America Inc. Announces the Appointment of John Bier as Product Manager
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Danvers, Massachusetts, July 9, 2003. TÜV America Inc. announces the
appointment of John Bier as Product Manager of their Medical
Health Services division for the central U.S. region. This appointment
extends Mr. Bier’s longstanding association with TÜV America and TÜV
Product Service GmbH in Munich, Germany. Mr. Bier was named Product
Manager on July 7, 2003 and will reside at TÜV America’s New Brighton,
MN facility. He can be reached at 651-638-0250 or jbier@tuvam.com.
“We are enthusiastic about John’s acceptance of this key position,”
stated Mark Alpert, TÜV America, VP Central Region. “His solid
regulatory affairs and quality assurance background serve as a perfect
knowledge base for building a strong future of customer service and
growth. John’s knowledge of the clients, the region and the TÜV
organization makes him a valuable addition to the TÜV team.”
Mr. Bier is the founder and principal of a consulting firm providing
quality systems, domestic and international regulatory, employee training,
and internal and supplier assessment services to medical device
manufacturers. His prior background includes Regulatory Affairs/Quality
Assurance management and supervisory positions in various settings, as
well as extensive experience as a Notified Body Auditor and Certified Lead
Auditor performing medical device evaluations to determine client
compliance with Medical Devices Directives and European Norm requirements.
About TÜV America Inc.
TÜV America Inc., a subsidiary of Group TÜV Süddeutschland, the leading
TÜV organization in Germany, employs over 220 professionals throughout
the NAFTA region, including Danvers (MA), New Brighton (MN), San Diego
(CA), San Ramon (CA), Knoxville (TN), Monterrey (Mexico) and many
additional locations. TÜV America Inc. offers a wide range of services
through the globally recognized brand names of TÜV Product Service,
Management Service and Industry Service.
TÜV America Inc., Product Service division, is a leading EU Notified Body
for the Medical Devices, Active Implantable Medical Devices and In Vitro
Diagnostic Directives. TÜV also provides ISO 9000, ISO 13485/88, EN 46000
and ISO 14001 certification; SCC qualified ISO 13485 Registrar for the
Canadian Medical Devices Regulations; FDA 510(k) reviews; electromagnetic
compatibility (EMC); NRTL certification to ANSI/UL 2601; SCC Certification
Body services; electrical, mechanical and functional safety testing; and
many additional global conformity assessment services. Globally, TÜV has
issued over 130,000 product and 12,000 quality management system
certifications.
###
For more information contact:
Lori O’Neill
Marketing Communications Specialist
TÜV America Inc.
(978) 739-7005
loneill@tuvam.com
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TÜV
America Inc. Receives SCC Certification Body Accreditation
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Danvers, Massachusetts, June 4, 2003. TÜV America’s Product Service
division announces it has received official notice of accreditation from
the Standard Council of Canada (SCC) as a certification body in accordance
with Standards Council document CAN-P-3G, General Requirements for Bodies
Operating Product Certification Systems, on June 4, 2003. Accreditation as
a Certification Body from the SCC allows TÜV to perform electrical
safety testing and certification to Canadian electrical safety
standards (CSA/SCC) for products marketed in Canada.
TÜV is accredited to provide testing pertaining to the safety and Electromagnetic
Compatibility (EMC) of all types of electrical and electronic
products, systems and related services including Information Technology
and Office Equipment: computing devices, peripheral devices, electronic
office equipment, telecom equipment; Testing, Measurement and Laboratory
Equipment: electrical equipment for laboratory use, electrical measuring
and test equipment; Audio and Video Equipment: video equipment and
accessories, audio equipment and accessories, musical instruments and
accessories; and Electro-Medical Equipment: patient care equipment,
patient monitors, x-ray equipment, dental equipment, hospital beds.
SCC accreditation allows TÜV to provide the ultimate service package:
Canada, United States and Europe or “CUE.”
By simultaneously testing products for electrical safety compliance to
Canadian (CSA), the United States (UL/ANSI) and European (IEC/EN)
electrical standards, organizations will shorten their products’ time to
market, while decreasing overall compliance costs.
To complement the above mentioned testing/certification services, TÜV
America’s Management Service division is a SCC Accredited Quality
Management Systems Registrar and an RAB Accredited Registrar, able to
provide management
systems certifications to numerous product categories including
Information Technology, Machinery and Equipment, and Electrical and
Optical Equipment.
About TÜV Product Service Division
TÜV America Inc., Product Service division, is a globally recognized
testing / certification organization providing CE Marking assistance,
mechanical/electrical product safety, electromagnetic compatibility (EMC),
NRTL certification, and performs European Union Notified Body services for
a variety of EU directives. Additionally, TÜV provides a full suite of
globally recognized ISO Management System certifications including ISO
9000 and ISO 14001. Globally, TÜV has issued over 130,000 product and
12,000 quality management system certifications.
##
For more information, contact:
Gary Minks
TÜV America Inc.
Director of Certification Body
(978) 739-7021
gminks@tuvam.com
For editorial information, contact
Lori O’Neill
TÜV America Inc.
Marketing and Communications Specialist
(978) 739-7005
loneill@tuvam.com
|
| TÜV
Product Service Implements a new 3-in-1 Testing / Certification Service
Program |
Danvers Massachusetts, February 11, 2002. TÜV Product Service, the
Machinery, Information Technology, and Consumer Product Division of TÜV
America Inc. is now offering a new 3-in-1 Testing / Certification
service, code-named “CUE” for Canada, United States and the European
Union. The CUE Certification
program was designed to decrease the time it takes to complete global
product safety certification through multiple testing, thereby
accelerating the product’s time to market, providing organizations the
means to access and excel in global markets. TÜV Product Service will
simultaneously determine compliance to Canadian (CSA/SCC), the United
States (UL/ANSI) and European (EN/IEC) safety standards, thus providing
a unique 3-in-1 certification.
 ”As a third-party testing
laboratory with decades of experience in electrical safety we
understand, manufacturers need to keep their product
development/production schedule on-time and within budget. Our “CUE”
3-in-1 Certification Program was created specifically to assist clients
in accomplishing this extremely important goal”, stated Vincent
Hawxhurst, Director Compliance Engineering, TÜV Product Service.
As a SCC (Standards Council of Canada) recognized testing laboratory, an
NRTL (Nationally Recognized Testing Laboratory) for the United States,
and a European Notified Body, TÜV Product Service will be capable of
providing manufacturers with the ultimate product safety certification
package. “CUE” Canada, US, and Europe product safety certification,
the three most sought-after markets in the world.
About TÜV Product Service
A European Union Notified and Competent Body, an NRTL (Nationally
Recognized Testing Laboratory), TÜV Product Service provides
comprehensive support services including product certification, CE
Marking assistance, electromagnetic compatibility (EMC), electrical,
mechanical and functional safety testing, and many additional global
conformity assessment services. Together with TÜV Management Service,
we are a leading ISO 9000 registrar in the US, Europe and Asia.
A division of TÜV America Inc., the company employs over 240
professionals throughout North America, including Danvers (MA),
Knoxville (TN), New Brighton (MN), Boulder (CO), San Diego (CA), Santa
Clara (CA) and additional locations. A subsidiary of TÜV Süddeutschland
AG (Munich, Germany) the company employs over 9,200 professionals in
more than 30 countries. Globally, TÜV has issued over 24,000 product
and 12,000 quality management system certifications.
# #
For more information, contact:
Vincent Hawxhurst
TÜV Product Service
Director Compliance Engineering Services
(978) 739-7073
vhawxhurst@tuvam.com
For editorial information, contact
Lori O’Neill
TÜV Product Service
Marketing and Communications Specialist
(978) 739-7005
loneill@tuvam.com |
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TÜV America
Inc. Receives NRTL Recognition from OSHA
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Danvers Massachusetts, January 28, 2002. TÜV America Inc. announces they
have received official notification of recognition as an NRTL (Nationally
Recognized Testing Laboratory) from OSHA (Occupational Safety & Health
Administration) on January 25, 2002. Recognition as an NRTL from OSHA is
an acknowledgement that TÜV has the necessary qualifications to perform
safety testing and certification of products to specific product standards
covered within the scope of recognition. NRTL activities will be conducted
by TÜV Product Service, the testing and certification division of TÜV
America Inc.
By becoming an NRTL, TÜV America Inc. is authorized to provide electrical
safety certification to North American requirements for Machinery, ITY
Equipment, Medical Devices and Consumer Products. Electrical safety
testing to UL/ANSI Standards include: UL/ANSI 508 for Industrial Control,
UL/ANSI 1950/60950 for ITY Equipment (including Electrical Business
Equipment), UL/ANSI 3101 for Electrical Equipment for Lab Use, Part 1
General Requirements, and UL/ANSI 2601 for Medical Electrical Equipment,
Part 1 General Requirements for Safety, and more.
“Gaining NRTL accreditation will greatly benefit our clients by
decreasing the time it takes to complete global product safety
certification through multiple testing, thereby accelerating the
product’s time to market,” stated Vincent Hawxhurst, Director
Compliance Engineering Services, TÜV Product Service.
TÜV Product Service (Testing & Certification division of TÜV America
Inc.) laboratories in North America underwent the required OSHA audits in
March 2001 experiencing no major preliminary findings. TÜV America’s
notice of application was published in the Federal Register on November
23, 2001 initiating the “public review and comment period”, with no
negative reviews received. The Assistant Secretary rendered a final
decision on January 25, 2002 with the “Public Announcement” of
recognition being published in the Federal Register, officially announcing
TÜV America Inc. as an NRTL.
About TÜV Product Service
A European Union Notified Body, a Nationally Recognized Testing Laboratory
(NRTL) for the US, and pending Standards Council of Canada (SCC)
recognition, TÜV Product Service provides comprehensive support services
including product certification, CE Marking assistance, electromagnetic
compatibility (EMC), electrical and mechanical safety testing, as well as
many additional global conformity assessment services. Together with TÜV
Management Service, we are a leading ISO 9000 registrar in the US, Europe
and Asia.
A division of TÜV America Inc., a subsidiary of TÜV Süddeutschland
Holding AG (Munich, Germany), the company employs over 250 professionals
throughout North America, including Danvers (MA), Knoxville (TN), New
Brighton (MN), Boulder (CO), San Diego (CA), San Ramon (CA), Santa Clara
(CA) and many additional locations. Globally, TÜV has issued over 24,000
product and 12,000 quality management system certifications.
# #
For more information, contact:
Vincent Hawxhurst
TÜV Product Service
Director Compliance Engineering Services
(978) 739-7073
vhawxhurst@tuvam.com
For editorial information, contact
Lori O’Neill
TÜV Product Service
Marketing and Communications Specialist
(978) 739-7005
loneill@tuvam.com |
|
TÜV
Management Service First Global Registrar to Receive CMDCAS Recognition
From the SCC
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|
Danvers, Massachusetts. August 23, 2001. TÜV
America Inc. announces that its registrar division, TÜV Management
Service, has received accreditation from Standards Council of Canada (SCC)
www.hc-sc.gc.ca and Health Canada as
a Canadian Medical Devices Conformity Assessment System (CMDCAS)
recognized registrar on August 8, 2001. CMDCAS recognition enables TÜV to
perform accredited ISO 13485 / 13488 quality systems certification
services for medical device manufacturers marketing their products in
Canada through the Medical, Health and Sports division of TÜV Product
Service. TÜV becomes the first registrar in the world to be CMDCAS
recognized by Health Canada and the SCC to provide ISO 13485 / 13488
certification. Combined with TÜV Product Service's full suite of medical
services and status as the leading Notified Body for the EU Medical
Devices Directive, clients can receive all their conformity assessment
services from one leading organization.
To date, Health Canada is the first national regulatory body to require a
specific quality systems standard, ISO 13485 / 88 as a prerequisite to
device licensing requirements necessary to conduct business in Canada.
Published on May 7, 1998 the device and establishment licensing
requirements found in sections 43 and 44 of the Canadian MDR (Medical
Device Regulations) came into force on January 1, 1998. The quality
systems requirements found in sections 32 (2) (f), 3 (5) and 4 (p) due to
come into effect July 1, 2001, have been amended and will now come into
force eighteen months later on January 1, 2003. Beginning July 1, 2001, a
voluntary transition period will begin for all manufacturers of applicable
(class 2-4) medical devices in the Canadian marketplace to receive ISO
13485 / 88 by a CMDCAS recognized registrar (TÜV Management Service). As
of January 1, 2003 manufacturers of class 2-4 medical devices not already
in the Canadian market must submit an appropriate CMDCAS ISO 13485 / 88
quality system certificate to Health Canada along with their device
license application. Annual renewal of the latter is required each
November. Manufacturers whose class 2-4 devices are already licensed to
market in Canada have until November 1, 2003 to submit appropriate CMDCAS
ISO 13485 / 88 certificates with their renewal applications.
(ISO 13485 and 13488:1996 are quality management standards specific to the
medical device industry, which supplement ISO 9001 and ISO 9002:1994
quality management systems standards)
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Canadian
Requirements
|
To date, Health Canada is the first national regulatory
body to require a specific quality systems standard, ISO 13485 / 88 as a
prerequisite to device licensing requirements necessary to conduct
business in Canada.
Manufacturers of Class 2 devices must comply with the
requirements for ISO 13488 and manufacturers of Class 3 and 4 devices need
to meet the requirements for ISO 13485. Accreditation to these standards
must be achieved by a Health Canada recognized SCC accredited registrar.
The SCC is deeming these registrars Canadian Medical Devices Conformity
Assessment System (CMDCAS) registrars.
TÜV Management Service, the registrar division of TÜV
America Inc., is the first registrar to receive accreditation by the SCC
and Health Canada as a CMDCAS recognized registrar. This accreditation
enables TÜV Management Service to provide clients ISO 13485 or ISO 13488
certification for medical device manufacturers selling their product in
the Canadian marketplace. Combined with TÜV Product Service's full suite
of medical services and status as the leading Notified Body for the EU
Medical Devices Directive, clients can receive all their conformity
assessment services from one leading organization, TÜV Product Service.
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About CMDCAS
Published May 7, 1998 the device and establishment licensing requirements found
in sections 43 and 44 of the Canadian MDR (Medical Device Regulations) came into
force on January 1, 1998. The quality systems requirements found in sections 32
(2) (f), 3 (5) and 4 (p) were due to come into effect July 1, 2001, have been
amended and will now come into force eighteen months later on January 1, 2003.
Beginning July 1, 2001, a voluntary transition period will begin for all
manufacturers of applicable (class 2-4) medical devices in the Canadian
marketplace to receive ISO 13485 / 88 by a CMDCAS recognized registrar (TÜV
Management Service). As of January 1, 2003 manufacturers of class 2-4 medical
devices not already on the Canadian market must submit an appropriate CMDCAS ISO
13485 / 88 quality system certificate to Health Canada along with their device
license application. Annual renewal of the latter is required each November.
Manufacturers whose class 2-4 devices are already licensed to market in Canada
have until November 1, 2003 to submit appropriate CMDCAS ISO 13485 / 88
certificates with their renewal applications.
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