Your Compliance Journey Starts Here

Providing End-to-End Consulting Services for the Life-Cycle Management of Medical Devices and Diagnostics

Professional Services

Business Case

A strong business case is vital, guiding decisions by evaluating market opportunities, financial viability, and regulatory factors.

Market and Competitor Analysis

Conducting thorough market analysis is critical, aiding in identifying target audiences, understanding competitors, and assessing regulatory requirements.

Design and Development

Design and development plays a pivotal role in ensuring the safety, performance, and usability of medical device products.

Quality Management

Irrespective of device classification, a Quality Management System is the cornerstone of the life cycle development of all medical devices.

Software Development

Medical device software development requires meticulous planning, rigorous testing, and strict adherence to regulatory standards for reliability, safety, and effectiveness in healthcare.

Legal Services

We provide patent searches & analysis, patent filing and prosecution, and ensure brand protection.

Regulatory

Our services include global regulatory strategies for AU, US, EU.

Risk Management

Guidance on conducting thorough risk assessments and implementing effective mitigation strategies throughout the development process.

Post Market Vigilance

Continuous monitoring and evaluation of products after their release to market

Project Management

Agile Project Management for your software development project

Life Coaching and Mentoring

Personal or professional, whatever your challenges may be, visit https://beyondtheshell.com.au/

Clinical Evaluation

Gathering and analyzing clinical data to ensure regulatory requirements are adheared to.

Free Introductory Call

Discover the tailored benefits our professional services can offer your business

Book Free Consultation

What Our Clients Are Saying

P6 Medical

Shannon Walter-Engelsma: Director

"It has been a privilege and an honour to work with Paul Cohen. He has brought a wealth of knowledge to our project and has helped us negotiate many unforeseen obstacles including Brexit, COVID 19, and a full change of business structure. Throughout these challenges Paul has proven to be loyal, reliable, and consistent at achieving all deliverables requested whilst considering all alternatives to achieve our targets."

Cryosite

Alicia Steel: Chief Quality Officer of Cryosite and Board member on ISPE

“Paul has been an invaluable leadership coach for our team, guiding us through the intricacies of GMP regulatory changes, quality control, and change management. His expertise and personalized approach have empowered our young managers to navigate complex challenges with confidence and clarity. Paul's tailored coaching sessions have fostered a culture of adaptability and continuous improvement within our organization. I highly recommend DevDx to any organization seeking expert guidance in navigating today's ever-evolving GMP regulatory landscape.”

Minomic International Ltd

Yanling Lu (PhD): Head of CMC (Chemistry, Manufacturing and Controls)

"Paul has extensive up-to-date knowledge of quality and regulatory requirements for the medical device industry. He has worked with many SMEs in the field and is flexible and adaptable to help SMEs to deliver cost-effective and efficient solutions. We have enjoyed working with Paul to establish Minomic’s QMS for ISO13845. Paul has given us guidance and played a critical role in the commercial launch of our MiCheck® Prostate test."

ResusRight

Matt Boustred: Co-Founder and CEO

"As a startup we were looking for a QMS. Having Paul's experience and wisdom on board was hugely beneficial. He deeply cared about our company and took care to design and then implement quality strategies to get us to where we needed to be, including going above and beyond educating the whole team to ensure we understood not only what we needed to do but the purpose behind it. I couldn't recommend him highly enough."