What We Do?

Cdaqi provides short term quality control (QC) and regulatory affairs (RA) outsourcing for assistance with medical device registrations, QMS compliance, vigilance reporting and more.
In today’s fast changing and increasingly complex regulatory environment, it can be difficult to manage compliance to an ever-changing array of medical device regulations in multiple countries. Many medical device companies are choosing to outsource some of their regulatory affairs and quality control tasks as a way to manage compliance in these worldwide markets.
Whatever your situation, Cdaqi can help you maintain regulatory compliance, enhance your quality system, and most importantly, concentrate on your core business objectives.
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Qc/Ra Advisory Service
Medical Regulatory Services:
- System implementation assistance as per QSR 21 CFR Part 820 requirements
- System implementation assistance as per ISO 13485:2003/EN ISO 13485:2012 requirements
- 510K submission/ Assistance for Pre Market approval(PMA)
- Technical File submission as per 93/42/EEC requirements for CE Marking
- Computer System Validation(USFDA 21 CFR Part 11)
- Risk Management Process as per ISO 14971:2007/EN ISO 14971:2012

EU MDD to EU MDR Transition
- The EU Medical Device Regulation was designed to protect the fitness and safety of European Union residents. It officially replaced the Medical Device Directive (MDD) in May 2021, with the aim of enhancing safety for European patients through a more robust and transparent framework. It brings medical devices regulation in line with technical advances, changes in medical science and progress in law making.
- The requirements for MDR are more robust than MDD, and MDR covers a greater range of products. Once the transition period has elapsed, all applicable products must comply with MDR.
Risk management
- Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators, or the environment.
- The requirements for MDR are more robust than MDD, and MDR covers a greater range of products. Once the transition period has elapsed, all applicable products must comply with MDR.
- In the medical device industry, risk management goes beyond development and manufacturing; it is a vital part of all your organization’s processes.
- ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire life cycle of a device.
- Risk Management is one of the major requirements for a medical device. Our consultants work hand-in-hand with you and your team to develop strategic solutions that will address your specific needs.
- We provide support throughout your entire product development cycle to help you navigate the complexities of building a Risk Management File to incorporate risk analysis, hazard analysis, production/post-production device monitoring, and more.