Medical Device Consultancy
Expert Support for Medical Device Compliance and Innovation
As a medical device consultancy, we are dedicated to advancing the quality and regulatory compliance of your medical devices. Whether you are bringing a product idea to life or enhancing an existing product, our expertise in quality assurance and regulatory compliance will help ensure that through your product development, your medical devices meet compliance through national and international standards and safeguard patient safety and achieve their designed purpose and use.
Navigating the complexities of regulations, classifications, and standards within the medical device industry can often seem daunting, but we can help you with these challenges, offering you the guidance and support needed to navigate the regulatory landscape with ease.
By ensuring compliance and streamlining your processes, we aim to help you enhance your organisation’s efficiency, reduce operational costs, and boost your overall success rate.
Our Medical Device Consultancy Services:
- Regulatory strategy analysis
- Auditing
- Gap analysis
- Quality management system support and implementation
- Global registrations
- CE and UKCA marking
- Conformity Assessments
- Technical documentation – creation, review, remediation, maintenance and enhancements
- Continuous improvement strategies
- EU MDR 2017/745 transition
Key changes to Medical Device Regulation EU MDR 2017/745
The purpose of the new MDR was to resolve some problems in old directives and keep up with rapid advancements in science and technology. To achieve this, several important changes were brought in, including:
- Stricter pre-market control will be implemented for high-risk devices through a new scrutiny mechanism involving a pool of EU-level experts.
- The reinforcement of the criteria for designation and processes for oversight of Notified Bodies.
- The inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these regulations.
- Improved transparency through the establishment of a comprehensive EU database on medical devices and a device traceability system based on Unique Device Identification (UDI).
- The introduction of an “implant card” containing information about implanted medical devices for a patient.
- The reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations.
- The strengthening of PMS requirements for manufacturers.
- Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.
Navigating EU MDR 2017/745 with confidence
The shift from the Medical Device Directive (MDD) to the Medical Devices Regulation (MDR) 2017/745 signifies a substantial change, necessitating a deeper commitment from medical device businesses. QAEC Limited has a proven track record of successfully guiding and supporting medical device companies through the transition to EU MDR 2017/745.
Even if you have completed the work on the transition process yourself but still have some uncertainties, QAEC Limited can still help, by reviewing your documentation and providing advice and guidance as your regulatory partner, supporting you at every level.
QAEC Limited is here to simplify the complexity of regulatory requirements for you.
QAEC Limited is your partner to successfully manage your QMS alignment from the MDD to UK MDR 2002 and the MDD to EU MDR 2017/745 transition, helping ensure your medical devices are compliant, effective, and ready to meet the needs of the market. We can help ensure that your business processes and quality management system align with current and new products throughout their life cycle, by developing a strong regulatory strategy.
Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.
Contact us today at +44 (0)1452 341913 or enquiries@qaeclimited.co.uk to discuss how we can support your medical device projects, remediation, implementation and continuous improvement of your quality management system as your quality and regulatory specialists.
LET’S CONNECT
If you would like to find out more about our range of services or have a question you would like to ask us, we are here to help.
