Find the nearest office SOLUTIONS EXPERTISE RESOURCES CONTACT CAREERS ABOUT NEIGHBORHOOD VCLS INNOVATION CENTER VCLS SOLUTIONS BY STAGE OF MEDICAL DEVICE DEVELOPMENT COMMERCIALIZATION & POST-MARKET By Stage of Medical Device Development COMMERCIALIZATION & POST-MARKET Concept & Feasibility Analyze prototype and concept design Preclinical Development Evaluation of biocompatibility and safety. Analytical validation Clinical Development Assess safety and effectiveness, and gather data for registration and market access Market Approval Assemble and file an application Commercialization & Post-Market Mitigate risk and remain compliant Mitigate risk and remain compliant. Post marketing surveillance (PMS) is organized to monitor the safety and performance of the product once used by large number of patients in the targeted population, and to ensure a sustainable risk/benefit balance. Agreements are established with distributors in particular to define the split of regulatory responsibilities between the different stakeholders (Manufacturer/distributor). Promotional materials are developed for each market, in compliance with local regulatory requirements. Launch, pricing, and reimbursement strategies aim to yield a favorable evidence-based assessment by national authorities, whose priorities and outcome measurement vary across markets. The medical device’s core value dossier is adapted for local reimbursement applications. CLIENT GOALS Post-market surveillance to maintain compliance Assess opportunities in new indications, product repositioning, need of additional clinical studies in new indications. Collect RW data Manage unexpected regulatory or safety issues. CHALLENGES Are the post-market surveillance procedures well defined and not too burdensome? How to optimize the post-approval regulatory plan? How to handle manufacturing changes/issues? How to manage competitive markets? How to identify additional market opportunities? How to extend the indication for use? Will pricing need to be re-negotiated? What will be the adequate evidence to support it? SOLUTIONS By Stage of Drug Development By Stage of Medical Device Development Product Expertise Industry Focused Therapeutic Areas Solutions for Switzerland Orphan Drugs VCLS COVID-19 Update PRESENTATION Digital health Navigate the maze of MDR for Medical Device Software This presentation is aimed at helping developers navigate the development and regulation maze of MDR for medical device software. Some… OUR MISSION Voisin Consulting Life Sciences is the global reference partner to expedite access of HealthTech products to regulated markets. ADVANCE WITH US WHAT VCLS CAN DO Post-market clinical follow-up studies Post-market compliance solutions and vigilance support Post-approval regulatory lifecycle management Maintain QMS BACK TO TOP VCLS EXPERTISE Access to Market Effectively positioning your product for the right indication from early stage of… Regulatory Strategy & Submissions Design and implementation of global patient-centric regulatory strategies to ensure expedited product… Vigilance From pre-market product safety to post-market surveillance and data analysis to meet… GET IN TOUCH --- 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 Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Cook Islands Costa Rica Croatia Cuba Curaçao Cyprus Czech Republic Côte d'Ivoire Democratic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kosovo Kuwait Kyrgyzstan Laos Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macau Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Northern Mariana Islands Norway Oman Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Islands Poland Portugal Puerto Rico Qatar Rennes st Gregoire Romania Russian Federation Rwanda Réunion Saint Barthélémy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Korea South Sudan Spain Sri Lanka State of Palestine Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syria São Tomé and Príncipe Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu USA Minor Outlying Islands Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela Vietnam Virgin Islands (British) Virgin Islands (USA) Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Select your country...* --- Search Engine Conference Referral Social Media (LinkedIn, Twitter) Webinar Neighborhood Event Neighborhood Website How did you hear about us ?* --- Biologic Drugs Cell, Gene and Tissue Therapy Chemical Drugs Classical Medical Device Combination Product Digital Medical Device E-Health/M-Health IVDs & CDx Microbiome-based Products Vaccines Other Product type...* *I have read and agreed to the Terms of Use and the Privacy Policy. 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