SERVICES
Certifications
ISO 13485 Certification
ISO 13485 is the international standard recognized for medical device regulations around the world.
It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.
ISO 13485: 2003: is the latest version of ISO 13485, published in July 2003. This standard is based on the ISO 9001:2000 process model approach. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation.
- Manufacturers of high-risk medical products must be associated with a notified body to vouch for the product's quality. This is achieved through product testing and auditing of the manufacturer's quality management system.
- Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective.
- Adoption of this standard assures the customers that the product complies with all relevant product and service-oriented technical standards and regulations
Business Association/Country Representation- Country Representation
- Progressive Certification services is looking for
competent associates from
Japan,
Russia,
Ukraine,
Bulgaria,
Italy,
Spain,
France,
Malaysia,
Middle Eastern Countries,
Canada,
Sri Lanka,
Tunisia,
Germany,
Brazil,
A
Afghanistan
Albania
Algeria
Andorra
Angola
Antigua & Barbuda
Argentina
Armenia
Australia
Austria
Azerbaijan
B
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bhutan
Bolivia
Bosnia & Herzegovina
Botswana
Brazil
Brunei
Bulgaria
Burkina Faso
Burundi
C
Cambodia
Cameroon
Canada
Cape Verde
Central African Republic
Chad
Chile
China
Colombia
Comoros
Congo
Congo Democratic Republic
Costa Rica
Cote d'Ivoire
Croatia
Cuba
Cyprus
Czech Republic
D
Denmark
Djibouti
Dominica
Dominican Republic
E
Ecuador
East Timor
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
F
Fiji
Finland
France
G
Gabon
Gambia
Georgia
Germany
Ghana
Greece
Grenada
Guatemala
Guinea
Guinea-Bissau
Guyana
H
Haiti
Honduras
Hungary
I
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
J
Jamaica
Japan
Jordan
K
Kazakhstan
Kenya
Kiribati
Korea North
Korea South
Kosovo
Kuwait
Kyrgyzstan
L
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
M
Macedonia
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Mauritania
Mauritius
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Morocco
Mozambique
Myanmar (Burma)
N
Namibia
Nauru
Nepal
The Netherlands
New Zealand
Nicaragua
Niger
Nigeria
Norway
O
Oman
P
Pakistan
Palau
Palestinian State*
Panama
Papua New Guinea
Paraguay
Peru
The Philippines
Poland
Portugal
Q
Qatar
R
Romania
Russia
Rwanda
S
St. Kitts & Nevis
St. Lucia
St. Vincent & The Grenadines
Samoa
San Marino
Sao Tome & Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Swaziland
Sweden
Switzerland
Syria
T
Taiwan
Tajikistan
Tanzania
Thailand
Togo
Tonga
Trinidad & Tobago
Tunisia
Turkey
Turkmenistan
Tuvalu
U
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States of America
Uruguay
Uzbekistan
V
Vanuatu
Vatican City (Holy See)
Venezuela
Vietnam
Y
Yemen
Z
Zambia
Zimbabwe
Argentina etc.