Medical Device Manufacturers

The fast increasing need for Medical Devices and the globalization of the market represent growing challenges for manufacturers and approval organizations.

The suppliers of medical devices must ensure that they are manufactured to meet or exceed the required safety and performance standards. Products can be placed in the market after fulfilling the regulatory requirements, which will impact the device design, development, testing, manufacturing, packaging and labeling.

Due to the strong focus from authorities on healthcare safety, medical device manufacturers need to document full compliance with national regulations. Nemko has throughout the last 35 years been testing and certifying Medical Devices and been a Notified Body for Medical Devices since the Directive was introduced in 1993.

Today Nemko has local companies in Europe, North America and Asia offering worldwide market access services to countries with additional requirements.

The medical services offered by Nemko include:

Medical Testing

Nemko has extensive experience testing many kinds of medical products according to:

• EN/IEC 60601-1 (General requirements for safety)
• EN/IEC 60601-1-xx (Collateral)
• EN/IEC 60601-2-xx (Particular) series of standards
• With over 50 part 2 (Particular) standards, Nemko can assist you to ensure product compliance

EMC testing of Medical Devices:

• EN/IEC 60601-1-2 EMC compliance Requirements for Medical Electrical Equipment
• EN/IEC 60601-2-xx (Particular) series of standards
• Nemko also offers a wide range of EMC testing services.

Notified Body Service for Europe / CE marking

Nemko is accredited according to EN 45011 (ISO/IEC Guide 65) and ISO/IEC 17025.

• Medical Devices Directive, Class I-m (measuring), I-s (sterile), IIa, IIb, III
• EC Declaration of Conformity; compiling of test reports and required documentation for the technical file (MDD Annex VII).
• EC Type Examination Certificate (MDD Annex III).
• Full Quality Assurance with reference to EN ISO 13485 (MDD Annex II).
• Production Quality Assurance with reference to EN ISO 13485 (MDD Annex V).
• Product Quality Assurance with reference to MDD Annex VI.
• EC Verification MDD Annex IV.

Management System Certification

ISO 13485:2003 is the quality management system for Medical Devices.

Compliance with ISO 13485:2003 is the first step in fulfilling European regulatory requirements and also helps to establish a Quality Management System necessary to pass an FDA audit in the United States.

In Europe, the conformity of Medical Devices according to EEC-decrees 93/42/EEC must be assessed before sale of a Medical Device is permitted.

The certification of a company’s Quality Management System according to ISO 13485:2003 and Directive 93/42/EEC by a Notified Body (such as Nemko) is necessary to obtain a certificate of conformity allowing CE marking and the permission to sell the Medical Device in the European Union.

Environmental Compliance

Today there is a growing emphasis placed on ensuring that your product is environmentally friendly. There are many regulations placed on products that require compliance with environmental directives. Nemko offers the following environmental services:

• Impact on product
• Impact on environment
• Working environment

Software evaluation

Software can play many different vital roles in medical devices.

1. Software may be used as a component, part or an accessory to a medical device
2. The software itself can be a medical device
3. Software may be used in the production of a device or used in implementation of the manufacturer's quality system
4. Nemko offers software evaluation according to current international standards, such as EN / IEC 60601-1-4 and EN / IEC 62304

Risk Management

The Medical Device Directive indirectly defines a comprehensive risk management system for such devices.

Nemko offers evaluation of Risk Management Systems according to EN ISO 14971.

Market access for Canada

Canadian Medical Devices Conformity Assessment System (CMDCAS) is required by the Standards Council of Canada to confirm that Medical Devices are manufactured under a certified quality management system that meets the criteria of the international standard ISO 13485:2003.

Market access for USA

Nemko delivers certificates for Medical Devices through a partner. Contact your local Nemko office and they will advise you on the requirements and assist you in the approval processes.

Market access for Japan

Based on our partnership with Cosmos, we can offer a simplified route to gain access to the Japanese market for medical products. Most of the necessary testing can be performed in Nemko's laboratories based on the IEC 60601 series of standards. At manufacturing sites, the required audit of the quality management system according to ISO 13485 can be performed by qualified Nemko personnel.

Market Access for China

For market access in China, Nemko is able to provide CCC Certification for medical products that fall under the CCC scope.

Wireless equipment used in Healthcare

Wireless equipment often has additional requirements before it can be imported and sold in many countries. Nemko offers worldwide market access to over 150 countries for wireless products through our Nemko Direct for Telecom program.