Regulatory And Compliance Services
Regulatory Strategy & Consulting
Guidance on regulatory requirements, strategy formulation for market entry, and advice on regulatory pathways.
Pre-market Regulatory Affairs
Assistance with regulatory submissions (e.g., FDA 510(k), PMA, CE Marking), including documentation preparation and submission management.
Post-market Surveillance & Vigilance
Support in setting up and maintaining post-market surveillance systems, handling adverse event reporting.
Product Registration
Product registration involves the process of obtaining approval from regulatory bodies to market and sell medical devices or in-vitro diagnostics (IVDs) in specific regions or countries.
This process requires the submission of detailed information about the product, including its design, manufacturing, intended use, and clinical data, to demonstrate compliance with regulatory standards and ensure patient safety and efficacy. Successful product registration results in the granting of a marketing authorization or license that allows the product to be sold within the regulatory jurisdiction.
Audit and Inspection Support
Support during regulatory inspections and audits, including preparation, on-site assistance, and response to findings.
International Regulatory Affairs
Guidance and support for obtaining approvals in international markets and managing submissions.
Biocompatibility and Safety Testing
Guidance on biocompatibility assessment, safety testing requirements, and coordination with testing laboratories.
Environmental 14001
Advice on compliance with environmental regulations and standards and sustainability practices.
Usability
Focus on designing medical devices that are safe and effective for intended users, tasks, and environments. Includes usability testing and human factors analysis to meet regulatory expectations and improve user satisfaction.
Electronics
Services focusing on the development, testing, and compliance of electronic components and systems within medical devices.
This includes ensuring the reliability, safety, electromagnetic compatibility (EMC), and performance of electronic circuits, power supplies, sensors, and actuators. Support may cover aspects such as circuit design, component selection, power management, signal integrity, and adherence to regulatory standards for electronic safety and EMC.
Sterilisation
Assistance with selecting and validating appropriate sterilization methods for medical devices, including microbiological testing and cleanroom compliance
Robotics
Support in the development and regulatory strategy for robotic medical devices, covering aspects such as safety, effectiveness, and human-machine interaction.
PRRC
The Person Responsible for Regulatory Compliance (PRRC) is a mandatory role defined by the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) for manufacturers and authorized representatives of medical devices and IVDs within the EU.
The PRRC ensures that the organization complies with the regulatory requirements set forth in the MDR or IVDR. Responsibilities include ensuring the conformity of devices in terms of their manufacture and documentation, maintaining technical documentation, the EU declaration of conformity, and overseeing post-market surveillance and reporting obligations.
UKRP
The UK Responsible Person (UKRP) is a requirement for non-UK manufacturers wishing to place medical devices or IVDs on the market in the United Kingdom following Brexit.
The UKRP acts on behalf of the manufacturer, taking responsibility for ensuring that the devices comply with the UK’s regulatory framework, including registration with the Medicines and Healthcare products Regulatory Agency (MHRA). The UKRP must be established in the UK and is accountable for ensuring that the necessary documentation to demonstrate compliance is available for inspection by the MHRA.
IVD
In-Vitro Diagnostics (IVDs) are medical devices and accessories used to perform tests on samples (such as blood, urine, and tissue) taken from the human body to help detect infection, diagnose a medical condition, prevent disease, or monitor drug therapies.
IVDs range from simple home-use tests to sophisticated laboratory instruments. The regulatory requirements for IVDs include ensuring their safety, quality, and performance before they can be marketed or used on patients. Compliance with these requirements involves rigorous clinical evaluation, quality management systems, post-market surveillance, and, in many cases, product registration with relevant authorities.
Regulatory Compliance
Assistance in ensuring ongoing compliance with regulatory requirements, including changes in regulations and standards.
CE Marking
If you are looking for a reliable and experienced CE Marking consultancy service for medical devices, you have come to the right place.
We offer a comprehensive range of services to help you navigate the complex regulatory requirements and ensure that your products comply with the relevant standards and directives.
Whether you need assistance with product classification, technical documentation, risk management, clinical evaluation, or post-market surveillance, we have the expertise and resources to support you throughout the entire process.
Contact us today to find out how we can help you achieve CE Marking for your medical devices.
UKCA Marking
If you are a manufacturer or supplier of medical devices in the UK, you need to comply with the new UKCA Marking requirements that came into force on 1 January 2021.
UKCA Marking is a new product certification scheme that replaces the CE Marking for goods sold in Great Britain. It covers most medical devices, including active implantable, in vitro diagnostic and general medical devices.
- Gap analysis and readiness assessment
- Technical documentation review and preparation
- Product testing and conformity assessment
- UKCA Marking application and declaration
- Post-market surveillance and vigilance
We have a team of experienced consultants who are well-versed in the UKCA Marking regulations and the relevant harmonised standards.
We can provide you with tailored advice and guidance to suit your specific needs and circumstances.
Whether you need a full-service solution or just some support along the way, we are here to help you achieve UKCA Marking compliance for your medical devices.
FDA Registration
Are you looking for a reliable and experienced partner to help you navigate the complex and challenging process of FDA approval for your medical devices? If so, you have come to the right place.
QReg specializes in providing FDA approval solutions for medical devices of all types and sizes. We have a team of experts who have extensive knowledge and experience in the regulatory requirements, standards, and best practices for FDA approval.
We can help you with every step of the process, from planning and strategy, to testing and validation, to documentation and submission.
Whether you need a premarket notification (510(k)), a premarket approval (PMA), a de novo request, or any other type of FDA approval, we can assist you with our customized and cost-effective services. Contact us today to find out how we can help you achieve your FDA approval goals.
Medical Device Registration
If you are looking for a reliable and experienced partner to help you with the registration of your medical devices, you have come to the right place.
We offer a comprehensive and customized consultancy service for medical device manufacturers, distributors and importers who want to enter or expand their market presence in different regions.
We can assist you with the preparation and submission of the required documentation, the communication with the regulatory authorities, the compliance with the applicable standards and regulations, and the post-market surveillance of your products.
Whether you need a CE mark, FDA approval, Health Canada license, TGA certification, or any other type of registration, we have the expertise and the network to make it happen. Contact us today and let us help you achieve your business goals.
Software as Medical Device (SaMD)
If you are looking for a reliable and experienced partner to help you with the registration of your medical devices, you have come to the right place.
We offer a comprehensive and customized consultancy service for medical device manufacturers, distributors and importers who want to enter or expand their market presence in different regions.
We can assist you with the preparation and submission of the required documentation, the communication with the regulatory authorities, the compliance with the applicable standards and regulations, and the post-market surveillance of your products.
Whether you need a CE mark, FDA approval, Health Canada license, TGA certification, or any other type of registration, we have the expertise and the network to make it happen. Contact us today and let us help you achieve your business goals.
- Determining the risk classification and applicable regulatory pathway for your SaMD
- Preparing the technical documentation and clinical evidence to support your SaMD's safety, performance and quality
- Conducting gap analysis and remediation to ensure your SaMD meets the relevant standards and best practices
- Liaising with the regulatory authorities and notified bodies to facilitate the submission and review of your SaMD application
- Providing post-market surveillance and vigilance support to monitor and report any adverse events or incidents involving your SaMD
With our expertise and experience in SaMD registration, we can help you achieve compliance and market access for your innovative software solution. Contact us today to find out more about our consultancy service for medical devices.
Technical File
If you are looking for a reliable and experienced partner to help you with your technical file preparation for medical devices, you have come to the right place.
We offer a comprehensive and customized consultancy service that covers all aspects of the technical documentation required for CE marking and other regulatory approvals.
Whether you need assistance with risk management, clinical evaluation, usability engineering, biocompatibility testing, or any other technical file component, we can provide you with the guidance and support you need.
Our team of experts has extensive knowledge and experience in the medical device industry and can help you navigate the complex and ever-changing regulatory landscape. Contact us today to find out how we can help you achieve your goals and ensure compliance with the highest standards of quality and safety.
Post Market Surveillance (PSUR)
Post market surveillance (PMS) is a vital process for ensuring the safety and effectiveness of medical devices after they are placed on the market.
PMS involves collecting and analyzing data on the performance, adverse events, and user feedback of the devices.
A PMS consultancy service can help medical device manufacturers design and implement a PMS plan that complies with the regulatory requirements and best practices.
QReg can also provide support for conducting post-market clinical follow-up (PMCF) studies, risk management, vigilance reporting, and corrective and preventive actions (CAPA).
Clinical Evaluation Report (CER)
A clinical evaluation report (CER) is a document that summarizes the clinical data and evidence for a medical device. A CER is required for obtaining and maintaining the CE mark, which allows the device to be marketed in the European Union.
QReg can help medical device manufacturers to prepare, update and maintain their CERs in compliance with the relevant regulations and standards. We can also provide expert advice on the clinical evaluation process, the literature review, the clinical data analysis, and the risk-benefit assessment of the device.
Biocompatibility Evaluation Report
UK Responsible Person (UKRP)
If you are a manufacturer of medical devices outside the UK, you need to appoint a UK responsible person to act on your behalf.
A UK responsible person consultancy service can help you with the regulatory requirements and compliance for your products. They can also provide you with guidance and support on the UK market access and post-market surveillance.
A UK responsible person consultancy service can be a valuable partner for your business in the UK.