AFFILIATES Quality VistaMed’s primary strategy is to achieve total customer satisfaction by supplying defect-free products on time – every time. We have an unrelenting commitment to quality and apply those principles rigidly throughout all our business processes. Quality at VistaMed VistaMed is committed to working with our clients to achieve their quality objectives. The team at VistaMed can assist with all the Quality and Regulatory requirements of your product/project, including: Design History File & Review Regulatory requirements of your product First Article Inspections / PPAP Product / Process Validations Process Capability Studies Gauge R&R Biocompatability testing Age / Shelf-Life testing Performance Testing Sterilisation Validation Clinical Review (Literature and/or Clinical Trials) Technical File CE / 510K / PMA Submissions ISO 13485 Certification ISO 14644 Class 7 and 8 Cleanrooms FDA Registered Manufacturing Sites – Registration Number : 3008328690 Can provide REACH Compliance information Can provide RoHS Compliance information Can provide cGMP Compliance information DOWNLOADS Certificate of Registration ISO:14001 - Carrick-on-Shannon (2015) PDF 1.82 MB Certificate of Registration ISO:14001 - R&D centre PDF 1.3 MB Certificate of Registration ISO:14001 - Rooskey PDF 1.27 MB Certificate of Registration ISO:50001 - Carrick-on-Shannon (2018) PDF 548.84 KB Certificate of Registration ISO: 13485 Carrick-on-Shannon (2016) PDF 715.87 KB Certificate of Registration ISO 45001 - Carrick-on-Shannon (2018) PDF 216 KB CONTACT Country * Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benelux Benin Bermuda Bhutan Bolivia Bosnia and Herzegowina Botswana Brasil Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Caroline, Mariana Cayman Islands Central African Republic Chad Chile China Christmas Island Columbia Comoros Congo Cook Islands Costa Rica Cote d Ivoire Croatia Cuba Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia Gabon Gambia Georgia Germany Ghana Gibraltar Great Britain Greece Greenland Grenada Guadeloupe Guam Guatemala Guinea Guinea Bissau Guyana Haiti Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Jamaica Japan Jordan Kazakstan Kenya Kiribati Korea Kosovo Kuwait Kyrgyzstan Lao People s Democr. Rep. Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macau Macedonia Madagascar Malawi Malaysia Maldives Mali Malta Marianna Islands Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldovia Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands Netherlands Antilles New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Norway Oman Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Puerto Rico Qatar Republic of South Africa Reunion Romania Russia Russian Federation Rwanda Saint Kitts and Nevis Saint Lucia Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia Spain Sri Lanka St. Helena St. Pierre and Miquelon St. Vincent/Grenadines Sudan Suriname Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thahiti Thailand Togo Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United States of America Uruguay Uzbekistan Vanuatu Vatican City State Venezuela Viet Nam Virgin Islands Virgin Islands (British) Yemen Yugoslavia Zaire Zambia Zimbabwe I hereby consent to the processing of my data in accordance with the Privacy Policy. * I would like to receive occasional emails from Freudenberg Medical regarding new products and services. © 2021 Freudenberg Medical TERMS PRIVACY POLICY CALIF. TRANSPARENCY IN SUPPLY CHAIN ACT LEGAL NOTICE SITEMAP Follow Us: