Resources Safetek Regulatory Services
Welcome to Safetek’s Resource Hub! Your go-to destination for all things regulatory
compliance and market access for medical devices. Explore tailored resources for success.
MDSAP Consultancy
Learn more about the Medical Device Single Audit Program (MDSAP), a regulatory program that allows medical device manufacturers to undergo a single audit to meet the requirements of multiple regulatory authorities. Our MDSAP consultancy resources provide an overview of the program, its benefits, and the steps involved in achieving MDSAP certification.
Certification Support
Access a range of resources to support you in obtaining the necessary certifications for your medical devices. From understanding the different certification pathways to preparing the required documentation, our resources will guide you through the certification process, enabling you to achieve compliance efficiently.
Regulatory Guides
Access our in-depth regulatory guides that provide valuable insights into the certification processes, regulatory requirements, and documentation needed for Brazil, Japan, USA, Australia, and Canada. These guides offer step-by-step instructions and tips to help you navigate the complexities of each regulatory landscape.
Safety and Biocompatibility Testing
Ensure the safety and effectiveness of your medical devices by exploring our resources on safety and biocompatibility testing. Discover the latest industry standards and best practices for conducting electrical safety, mechanical testing, biocompatibility assessments, and usability evaluations. These resources will help you navigate the testing process and meet regulatory requirements.
Regulatory Updates
Stay informed about the latest regulatory updates, changes in guidelines, and evolving industry trends. Our resources provide timely information on regulatory changes in Brazil, Japan, USA, Australia, and Canada, ensuring that you stay ahead of the curve and adapt your regulatory strategies accordingly.
FAQs and Glossary
Explore our frequently asked questions (FAQs) section, where we address common queries related to certification support, MDSAP consultancy, safety and biocompatibility testing, and more. Additionally, our glossary provides definitions of key regulatory terms, ensuring clarity and understanding as you navigate the regulatory landscape.
MDSAP Consultancy
Learn more about the Medical Device Single Audit Program (MDSAP), a regulatory program that allows medical device manufacturers to undergo a single audit to meet the requirements of multiple regulatory authorities. Our MDSAP consultancy resources provide an overview of the program, its benefits, and the steps involved in achieving MDSAP certification.
Certification Support
Access a range of resources to support you in obtaining the necessary certifications for your medical devices. From understanding the different certification pathways to preparing the required documentation, our resources will guide you through the certification process, enabling you to achieve compliance efficiently.
Regulatory Guides
Access our in-depth regulatory guides that provide valuable insights into the certification processes, regulatory requirements, and documentation needed for Brazil, Japan, USA, Australia, and Canada. These guides offer step-by-step instructions and tips to help you navigate the complexities of each regulatory landscape.
Safety and Biocompatibility Testing
Ensure the safety and effectiveness of your medical devices by exploring our resources on safety and biocompatibility testing. Discover the latest industry standards and best practices for conducting electrical safety, mechanical testing, biocompatibility assessments, and usability evaluations. These resources will help you navigate the testing process and meet regulatory requirements.
Regulatory Updates
Stay informed about the latest regulatory updates, changes in guidelines, and evolving industry trends. Our resources provide timely information on regulatory changes in Brazil, Japan, USA, Australia, and Canada, ensuring that you stay ahead of the curve and adapt your regulatory strategies accordingly.
FAQs and Glossary
Explore our frequently asked questions (FAQs) section, where we address common queries related to certification support, MDSAP consultancy, safety and biocompatibility testing, and more. Additionally, our glossary provides definitions of key regulatory terms, ensuring clarity and understanding as you navigate the regulatory landscape.
