US FDA Regulatory Services
US FDA Regulatory Services
- 510(k) Submissions
- Defining applicable ISO and IEC standards
- Letter to file (LTF) for changes to existing products
- Emergency Use Authorization (EUA)
- Breakthrough Device Designation
- Predicate selection
- Investigational Device Exemption (IDE)
- Establishment registration & listing with the US FDA
- PMA Submission l De Novo Submission l Pre-submission
- Identifying testing requirements
EU Regulatory Services
We fully understand the critical steps required to ensure conformity to European Union's Medical Device.
EU MDR
We are proficient in the following EU MDR services
- European Commission Regulation (EU) No. 2017/745 - Medical Device Regulation
- Classification of Device Using Annex VIII of the MDR QMS in compliance with ISO 13485
- CE Tech File or Design Dossier Preparation in accordance with Annex II and III
- UDI Registration in EUDAMED Database
- Clinical, PMS and PMCF activities
EU IVDR
We are proficient in the following EU IVDR services
- European Commission Regulation (EU) No. 2017/746 – In-Vitro Device Regulation
- Classification of Device Using Annex VIII of the IVDR
- QMS in compliance with ISO 13485 including PEP, PMS and PMPF
- CE Tech File or Design Dossier Preparation in accordance with Annex II and III
- UDI Registration in EUDAMED Database
- Performance Evaluation, PMS and PMPF activities
Health Canada MDL & MDEL
- Canadian medical device regulations
- Canadian medical device classifications
- MDL and MDEL applications
- ISO 13485 and MDSAP regulatory compliance
- Post approval device lifecycle management
International Registrations
- MHRA Registration
- UKCA Marking & Certification
- CE to UKCA Gap Analysis
- Australian TGA Approvals
- Indian CDSCO Registration
Services
Our other services
Quality Assurance
We pride ourselves on being experts in quality assurance , we are passionate about helping you meet high quality and sustainable Quality Management Systems.
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Product Development
Our experts combine their experience and know-how to build and update your device's design history in line with the quality systems and regulatory requirements.
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National Medical Products Administration (NMPA) is responsible for the regulation of Medical devices and Pharmaceuticals in China. The predecessor to NMPA was founded in 1998, and renamed as State Food and Drug Administration in 2003. On September 1, 2018 China Food and Drug Administration was replaced by NMPA and it operates under the state jurisdiction […]
In today’s world of healthcare, technology plays an important role in the life cycle of medical devices and software has become an integral part of majority of products that serve both medical and non medical purposes. There are three types of medical devices related to software. Namely, Software as a Medical Device (SaMD), Software in […]
Health Canada’s Medical Device regulations are considered to be one of the stringent requirements in the world for the licensing of medical devices. Regulation of medical devices in Canada is based on the level of risk possessed by the device to the user. This approach helps to balance the need to provide the healthcare system […]
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