About Us

Welcome to Safetek Regulatory Services, a trusted partner in regulatory compliance and quality assurance for medical device manufacturers worldwide.

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?

Safetek Regulatory Services offers unparalleled expertise and commitment to ensuring your compliance needs are met with precision and care. With our dedicated team and comprehensive approach, we provide peace of mind in navigating regulatory complexities. Choose Safetek for trusted guidance and unwavering support.

 Experience and Expertise

Time and Cost Efficiency

Comprehensive Support

Our Team

As a regulatory service provider, our dedicated team comprises highly qualified professionals with expertise in EU MDR, ISO 13485, and MDSAP compliance.
  • 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.

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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.

Regulatory Guidance and Training for a Start-up Medical Device Company

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.

Safety and Biocompatibility Testing for an Innovative Medical Device

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.

MDSAP Consultancy for a Global Medical  Device Company

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.

Certification Support for a Medical Device Manufacturer  in Brazil
Case Studies1
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.
Case Studies2
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. Our tailored consultancy ensured MDSAP audit success, expanding market reach and competitiveness.
safety-and-bio
Safety and Biocompatibility Testing for an Innovative Medical Device
This case showcases our expertise in safety and biocompatibility testing. Partnering with an innovative medical device manufacturer, we conducted rigorous assessments, including electrical safety, biocompatibility, and usability testing. Our comprehensive approach provided the manufacturer with vital data for regulatory compliance and a confident device launch.
Case Studie4
Regulatory Guidance and Training for a Start-up Medical Device Company
In this case, we provided tailored regulatory guidance and training to a medical device start-up, equipping them with the knowledge and tools to navigate regulations effectively. Our expertise helped develop a robust strategy, ensuring successful product launch while maintaining regulatory compliance.
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