Medical
IECEE CB scheme
The IEC CB scheme is by far the largest international certification scheme for products and is the closest there is to worldwide certification. It has more than 60 member countries, but it is also accepted outside these countries
ISO 13485:2003
ISO 13485:2003 is the quality management system for Medical Devices.
Compliance with ISO 13485:2003 is the first step in achieving compliance with European regulatory requirements for medical devices. It helps to establish a Quality Management System necessary to pass an FDA audit in the United States.
CE marking
This is the regulatory European product marking allowing access to the EU/EEA member countries (and even some EU candidate countries in Eastern Europe), as dictated by EU Directives and corresponding national regulations.
C-Nemko
Canadian electrical safety certification services
Nemko Canada has gained accreditation from the Standards Council of Canada (SCC) to certify electrical products to Canadian Electrical Safety requirements.
Nationally Recognized Testing Laboratory (NRTL) for the United States of America
Nemko has recently acquired an existing NRTL, CCL (Communication Certification Laboratory) in Salt Lake City, Utah. Through this acquisition, Nemko is now able to provide direct market access to the United States for products requiring NRTL certification for the product areas covering standards UL 60950-1, UL 60065 and UL 61010-1.
Medical certification
Notified Body Service for Europe / CE marking
Nemko is accredited according to EN 45011 (ISO/IEC Guide 65), and ISO/IEC 17025.
CMDCAS
Canadian Medical Devices Conformity Assessment System (CMDCAS) is required by the Standards Council of Canada to certify that Medical Devices are manufactured under a certified quality management system that meets the criteria of the international standard ISO 13485:2003.
Pre-Evaluation
Nemko can be your partner early in the product development cycle up until the product is placed in the marketplace. This will contribute to reducing costs and saving time.
Compliance Management
Compliance Management provides you with a dedicated project team responsible from start to finish to obtain market access for your product. By getting Nemko involved early in the product development cycle, you can avoid costly delays and frequent re-designs.
Nemko Direct for Other Industries
In addition to our Nemko Direct services for Information Technology, Audio Video, Household and Telecom products, we also offer our market access services for other industries upon request.
IQNet
Nemko AS is the only Norwegian member of the IQNet - The International Certification Network.
IQNet is the central body representing 36 national and international certification companies with a network of more than 200 subsidiaries worldwide. The IQNet certificate grants to customers the use of IQNet exclusive registered mark, which is known around the world as a synonym of Quality.
Medical safety testing
As a Notified Body (No. 0470) within the EU/EEA for Medical Devices Directive (MDD) 2007/47/EC (amending 93/42/EEC), we can cover your compliance needs for product requirements (IEC 60601 series) as well as Quality Management System (ISO 13485) requirements.
The Nemko Direct Program for more challenging international approvals – they truly are a fast and competitive alternative