Quality

Our team of consultants understand the process within medical device manufacturers, whether the product is hardware, software or diagnostics.

From building quality processes in production locations, establishing new CAPA and auditing systems to Vigilance activities, we spend our working days understanding the role of Quality professionals from start-ups with 10 people to the global players with 15,000+ employees.

Quality Management/
Quality Assurance

No two roles in quality management are the same, and we know that each company has its own challenges, projects and development plans that the QM function will bring to life.

Our network is built strongly on the foundation of knowing ISO 13485 and the documentation required for compliance, and from there understanding your focus in the device lifecycle.

Whether you are working broadly across the QM/RA topics or responsible for medical safety and CAPA - we have seen it all and want to hear about your challenges and aspirations.

CAPA and Validation

From building new CAPA systems to be compliant with the MDR or establishing a risk management reporting structure compliant to ISO 14971, we know the challenges and project focusses going through the medical device industry at any one time

Looking at manufacturing process validation and CSV, our network has technical expertise to comply with the quality standards requirements.

Auditing and Supplier Quality Assurance

Whether you are looking after the devices during production in QA, responsible for MDSAP implementation or visiting suppliers to ensure they are adhering your company quality assurance agreements, our consultants have covered roles all fields.

We understand the importance of strong negotiation, communication and stakeholder management skills to drive the relationship forward a smooth, compliant route to market.

PMS and Vigilance

Medical device safety is always at the top of everyone's mind in this industry. Our consultants are constantly updating their knowledge with regards to post-market surveillance requirements, PMS and PSUR reporting.

We have supported candidates to be successful in roles where safety forms part of a broader role, or for larger medical companies who need a dedicated safety professional responsible for a proactive and comprehensive vigilance system.

Read Our Blogs

Understanding ISO 27001 Standards: A Crucial Guide for Medical Device Industry Leaders

In today's digital age, safeguarding sensitive information is paramount, especially in the medical device, IVD, and biotech industries. As CEOs, COOs, VPs, and Presidents, understanding and adhering to ISO 27001 standards is not just a regulatory requirement but a strategic imperative. What is ISO 27001? ISO 27001 is an internationally recognized standard for information security […]

Emerging Technologies in the Medical Device Industry

The medical device industry stands at the intersection of healthcare and technology, continually evolving to improve patient outcomes and streamline medical processes. As we navigate the 21st century, several emerging technologies are set to revolutionize this sector. Let's explore these innovations and their potential impact. From smartwatches that monitor heart rates to wearable ECG monitors, […]

Understanding Wearable Medical Device Regulations

The rapid growth of wearable medical devices has revolutionized healthcare by enabling continuous monitoring and real-time data collection. From heart rate monitors to glucose sensors, these devices provide invaluable insights that can improve patient outcomes. However, as with any medical product, wearable devices must meet strict regulatory standards before they can be marketed and used. Understanding these […]

Global Trends in BioTech

Imagine a world where diseases are not just treated but predicted, where food scarcity is a thing of the past, and where the environment heals with the help of microscopic allies. Sounds like science fiction? Welcome to the future of BioTech! Let's embark on a journey through the global trends shaping the BioTech industry and […]

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