Streamline Compliance Audits for ISO 13485:2016 and FDA Title 21 CFR Part 820

Our template offers a structured framework, customizable features, and easy integration, enabling organizations to efficiently conduct audits and implement CAPA.

The Medical Audit & CAPA Template with Codebeamer  

Our Medical Audit & Corrective and Preventive Actions (CAPA) Template simplifies internal and external compliance audits for modern medical technology. It includes preconfigured artifacts, predefined assets and workflows for medical device development and compliance, and traceable links for easy audit preparation and execution. The Template also helps manage CAPA.  

With Codebeamer ready to use right out of the box, our Template offers instant access to best practices and regulatory compliant processes to provide health tech domain knowledge and act as an extension to Codebeamer. Reduce time and effort of configuring Codebeamer, ensure compliance, and minimize risks in developing complex health technology products. 

Please wait while your request is being submitted...

Hi {name}, welcome back.
Not you?

  • Country
  • Afghanistan
  • Albania
  • Algeria
  • American Samoa
  • Andorra
  • Angola
  • Anguilla
  • Antarctica
  • Antigua and Barbuda
  • Argentina
  • Armenia
  • Aruba
  • Australia
  • Austria
  • Azerbaijan
  • Bahamas
  • Bahrain
  • Bangladesh
  • Barbados
  • Belarus
  • Belgium
  • Belize
  • Benin
  • Bermuda
  • Bhutan
  • Bolivia
  • Bosnia and Herzegovina
  • Botswana
  • Bouvet Island
  • Brazil
  • British Indian Ocean Territory
  • Brunei Darussalam
  • Bulgaria
  • Burkina Faso
  • Burundi
  • Cambodia
  • Cameroon
  • Canada
  • Cape Verde
  • Catalonia
  • Cayman Islands
  • Central African Republic
  • Chad
  • Chile
  • China
  • Christmas Island
  • Cocos (Keeling) Islands
  • Colombia
  • Comoros
  • Congo
  • Congo, Democratic Republic
  • Cook Islands
  • Costa Rica
  • Cote d ivoire
  • Croatia
  • Cuba
  • Cyprus
  • Czech Republic
  • Denmark
  • Djibouti
  • Dominica
  • Dominican Republic
  • East Timor
  • Ecuador
  • Egypt
  • El Salvador
  • Equatorial Guinea
  • Eritrea
  • Estonia
  • Ethiopia
  • Falkland Islands (Malvinas)
  • Faroe Islands
  • Fiji
  • Finland
  • France
  • French Guiana
  • French Polynesia
  • French Southern Territories
  • Gabon
  • Gambia
  • Georgia
  • Germany
  • Ghana
  • Gibraltar
  • Greece
  • Greenland
  • Grenada
  • Guadeloupe
  • Guam
  • Guatemala
  • Guinea
  • Guinea-Bissau
  • Guyana
  • Haiti
  • Heard & McDonald Isl
  • Honduras
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Iraq
  • Ireland
  • Israel
  • Italy
  • Jamaica
  • Japan
  • Jordan
  • Kazakhstan
  • Kenya
  • Kiribati
  • Korea, Republic of
  • Kuwait
  • Kyrgyzstan
  • Lao Peoples Dem. Rep.
  • Latvia
  • Lebanon
  • Lesotho
  • Liberia
  • Libyan Arab Jamahiriya
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Macau
  • Macedonia
  • Madagascar
  • Malawi
  • Malaysia
  • Maldives
  • Mali
  • Malta
  • Marshall Islands
  • Martinique
  • Mauritania
  • Mauritius
  • Mayotte
  • Mexico
  • Micronesia
  • Moldova, Republic of
  • Monaco
  • Mongolia
  • Montenegro
  • Montserrat
  • Morocco
  • Mozambique
  • Myanmar
  • Namibia
  • Nauru
  • Nepal
  • Netherlands
  • Netherlands Antilles
  • New Caledonia
  • New Zealand
  • Nicaragua
  • Niger
  • Nigeria
  • Niue
  • Norfolk Island
  • Northern Mariana Islands
  • Norway
  • Oman
  • Pakistan
  • Palau
  • Panama
  • Papua New Guinea
  • Paraguay
  • Peru
  • Philippines
  • Pitcairn
  • Poland
  • Portugal
  • Puerto Rico
  • Qatar
  • Reunion
  • Romania
  • Russian Federation
  • Rwanda
  • Saint Helena
  • Saint Kitts and Nevis
  • Saint Lucia
  • Saint Pierre and Miquelon
  • Samoa
  • San Marino
  • Sao Tome and Principe
  • Saudi Arabia
  • Senegal
  • Serbia
  • Seychelles
  • Sierra Leone
  • Singapore
  • Slovakia
  • Slovenia
  • Solomon Islands
  • Somalia
  • South Africa
  • S.Georgia and S.Sandwich Isles
  • Spain
  • Sri Lanka
  • St. Vincent and Grenadines
  • Sudan
  • Svalbard and Jan Mayen Islands
  • Swaziland
  • Sweden
  • Switzerland
  • Taiwan
  • Tajikistan
  • Tanzania United Republic of
  • Thailand
  • Togo
  • Tokelau
  • Tonga
  • Trinidad and Tobago
  • Tunisia
  • Turkey
  • Turkmenistan
  • Turks and Caicos Islands
  • Tuvalu
  • Uganda
  • Ukraine
  • United Arab Emirates
  • United Kingdom
  • Uruguay
  • US Minor Outlying Islands
  • USA
  • Uzbekistan
  • Vanuatu
  • Vatican City State (Holy See)
  • Venezuela
  • Vietnam
  • Virgin Islands (British)
  • Virgin Islands (U.S.)
  • Wallis and Futuna Islands
  • Western Sahara
  • Yemen
  • Zambia
  • Zimbabwe

Click the button below to continue.

Submit