About Us
What we do?
MDSAP Consultancy
As the Medical Device Single Audit Program (MDSAP) gains prominence, compliance becomes essential for global market access. Our MDSAP consultancy services are designed to help manufacturers achieve compliance with this rigorous audit program. We offer comprehensive support in implementing MDSAP requirements, conducting internal audits, and preparing for MDSAP audits.
Certification Support
Navigating the complex certification process can be overwhelming. Our dedicated team provides end-to-end support in obtaining regulatory approvals for medical devices. We specialize in certification support for multiple regions, including Brazil, Japan, USA, Australia, and Canada. With our guidance, manPufacturers can streamline the certification process, saving valuable time and resources.
Safety Testing
Ensuring the safety and biocompatibility of medical devices is paramount. At Safetek Regulatory Services, we have advanced testing facilities and a team of experienced professionals to conduct a range of safety and biocompatibility tests. From electrical safety assessments to biocompatibility evaluations, we provide thorough and reliable testing services.
MDSAP Consultancy
As the Medical Device Single Audit Program (MDSAP) gains prominence, compliance becomes essential for global market access. Our MDSAP consultancy services are designed to help manufacturers achieve compliance with this rigorous audit program. We offer comprehensive support in implementing MDSAP requirements, conducting internal audits, and preparing for MDSAP audits.
Certification Support
Navigating the complex certification process can be overwhelming. Our dedicated team provides end-to-end support in obtaining regulatory approvals for medical devices. We specialize in certification support for multiple regions, including Brazil, Japan, USA, Australia, and Canada. With our guidance, manPufacturers can streamline the certification process, saving valuable time and resources.
Safety Testing
Ensuring the safety and biocompatibility of medical devices is paramount. At Safetek Regulatory Services, we have advanced testing facilities and a team of experienced professionals to conduct a range of safety and biocompatibility tests. From electrical safety assessments to biocompatibility evaluations, we provide thorough and reliable testing services.
Why Us?
Experience and Expertise
Time and Cost Efficiency
Comprehensive Support
Our Team
- Regulatory Specialists
- Quality Assurance Professionals
- Medical Device Experts
- Internal Auditors
- Accredited Testing Laboratory Partners
- Software Solutions
Industry Served
Cardiovascular Devices
We specialize in supporting manufacturers of cardiovascular devices, including pacemakers, stents, defibrillators, and implantable cardiac monitors. Our team is well-versed in the regulatory requirements and safety considerations specific to cardiovascular devices, ensuring compliance and facilitating market access.
Orthopedic Devices
From in-vitro diagnostic (IVD) kits to imaging systems, we have extensive experience in assisting diagnostic device manufacturers. Our team understands the unique regulatory challenges associated with these devices and provides tailored solutions to achieve compliance and streamline the certification process.
Diagnostic Devices
From in-vitro diagnostic (IVD) kits to imaging systems, we have extensive experience in assisting diagnostic device manufacturers. Our team understands the unique regulatory challenges associated with these devices and provides tailored solutions to achieve compliance and streamline the certification process.
Respiratory and Anesthesia Devices
Regulatory compliance is critical for manufacturers of respiratory and anesthesia devices, including ventilators, nebulizers, and anesthesia machines. Our expertise in this sector enables us to provide comprehensive support in obtaining the necessary certifications and complying with safety standards.
Rehabilitation and Assistive Devices
Orthopedic device manufacturers rely on our regulatory expertise to navigate the complex landscape of regulations governing products such as joint replacements, spinal implants, and orthopedic instruments. We assist in obtaining the necessary certifications and approvals, ensuring compliance with regional requirements.
Monitoring and Measuring Devices
Manufacturers of monitoring and measuring devices, such as blood pressure monitors, glucose meters, and medical scales, rely on our expertise to achieve regulatory compliance. We assist in obtaining certifications and approvals while ensuring adherence to safety and performance standards.
Surgical Instruments
Manufacturers of surgical instruments benefit from our regulatory support in ensuring compliance with regional requirements. We assist with certifications and approvals for instruments used in various surgical specialties, including neurosurgery, ophthalmology, and laparoscopy.
Implantable Devices
We assist manufacturers of implantable devices, such as orthopedic implants, dental implants, and neurostimulators, in achieving regulatory compliance. Our team understands the unique challenges associated with implantable devices and guides manufacturers through the certification process.
Case Studies
Regulatory Guidance and Training for a Start-up Medical Device Company
In this case, we provided regulatory guidance and training to a start-up medical device company. Our experts delivered customized training sessions, equipping the company with the knowledge and tools to navigate regulatory requirements effectively. We guided them in developing a robust regulatory strategy and addressing compliance challenges. As a result, the start-up successfully brought their innovative product to market while ensuring regulatory compliance.
Safety and Biocompatibility Testing for an Innovative Medical Device
This case highlights our expertise in safety and biocompatibility testing. We collaborated with a manufacturer of an innovative medical device to conduct a series of comprehensive tests to ensure its safety and biocompatibility. Our experienced team performed thorough assessments, including electrical safety, biocompatibility, and usability testing. The results provided the manufacturer with the necessary data to demonstrate compliance with regulatory standards and launch their device confidently.
MDSAP Consultancy for a Global Medical Device Company
In this case, a global medical device company sought our support in achieving compliance with the MDSAP. Our consultants conducted a thorough assessment of their quality management system, identified gaps, and guided the company in implementing MDSAP requirements. Through our tailored consultancy services, the company successfully passed the MDSAP audit, expanding their market reach and gaining a competitive edge.
Certification Support for a Medical Device Manufacturer in Brazil
In this case, we assisted a medical device manufacturer in navigating the complex certification process in Brazil. Our team provided comprehensive guidance, ensuring compliance with Brazilian regulatory requirements. By leveraging our expertise and knowledge of the local regulations, the manufacturer obtained the necessary certifications efficiently, enabling them to enter the Brazilian market successfully.