Medical Device Services
Medical Devices, due to their wide range of application, complexity and inherent risks, are heavily regulated across the globe.
Presafe´s portfolio of accredited and/or regulatory authorised services and network of experienced compliance specialists and auditors offers you a highly skilled and cost-effective ticket to trade to the global markets for Medical Devices.
We work with our customers through all the steps in the process, from training of stakeholders related to formal regulatory aspects as well as technical, pre-evaluations, to testing and certification.
Presafe´s Medical Devices Services are based on ISO 13485, EU Directives (MDD for Medical Devices and IVD for In-Vitro Diagnostics), the FDA and Canadian medical device regulations, as well as the Taiwanese regulations through the technical cooperation program between Taiwanese and European Authorities.
Presafe’s owner, DNV GL – Business Assurance, has a global presence with well qualified resources to locally provide conformity assessment activities on behalf of Presafe. DNV GL is also accredited to carry out electrical safety testing for medical equipment according to the IEC 60601 series of standards, as well as for Management System Certification to a number of international standards, globally.
The different schemes have their peculiarities, but Presafe will be there to guide you in the complex and to plan for a combined assessment. For MDD, as an example, the typical conformity assessment activities are:
• Technical documentation/file review or design dossier assessment
• Production quality assurance equivalent to ISO 13485 (excluding design) according to Annex V
• Full quality assurance equivalent to ISO 13485 according to Annex II
• EC verification according to Annex IV
• Guidance, interpretation and training related to the relevant directives for your products.
Technical documentation review and design dossier assessment typically take place at Presafe´s premises while quality system assessments are carried out at the customers’ sites. For more information, please go to Medical Device Regulations.