Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Developing our medical device business further is my key objective at TÜV SÜD. After some years of auditing and product assessment, leading a department of those experts and global management responsibility my focus moved towards innovation, digitalization, and future business opportunities.

Project management, GxP, Regulatory affairs, Clinical operations, Monitoring, Medical writing, MDR, PMCF, CER, Compliance, Notified Body interaction, ICH-GCP/ISO14155

Do you need help legally bringing your medical device to market in the UK, EU or USA? Feel free to send me a message to see how we can work together on achieving this 📧

Using my extensive knowledge of scientific, legal and business issues acquired throughout different aspects of my work, my main role is to ensure the appropriate licensing, marketing and legal compliance of medical devices to make sure that they reach the end consumer safely.

I see myself as a crucial link between the industry and the general public; as their bridge of trust to ensure that the medical products that they use are of a high quality standard and meet every guideline there is.

Moving forward, I am always willing to meet people from both the medical and healthcare industry to share their experiences and stories. If you take an interest to what I do or wish to contact me for business and/or other opportunities, please feel free to connect with me

Book a Microconsulting call with me: https://calendly.com/karandeepbadwal/microconsulting

Functional Areas of Focus:
- Medical Devices (ISO 13485, ISO 14971, MDR, Quality Management Systems, Technical File Remediation, ISO 11607, ISO 14644, IQ OQ, PQ, FDA CFR 21, GMP, 510k, IEC 62304, IEC 82304, Complaint Handling, CAPA, Sterilisation, Software Validation, Computer System Validation CSV, eQMS, Article 10(9)
- Regulatory Affairs (RA)
- Quality Assurance (QA/QC)
- Medtechn (SaMD, Digital Health, Artificial Intelligence/AI, Machine Learning)
- PRRC (Person Responsible for Regulatory Compliance)
- UKRP (UK Responsible Person)
- eQMS (Qualio, Greenlight Guru, JIRA, Atlassian, G Suite, Confluence)
- Certified QMS Auditor (CQI/IRCA)
- EU MDR Practitioner

My Content:
- How to build an ISO 13485 Quality Management System: Tinyurl.com/yagnzxm7
- ISO 13485 or ISO 9001 Quality Management Systems: Tinyurl.com/yavjg6kq
- Medical Device CAPA (Corrective Action and Preventative Action): Tinyurl.com/ycqubsba
- ISO13485 V FDA CFR 21 Part 820: Tinyurl.com/y94bkf5w
- How To Obtain A European CE Mark: Tinyurl.com/yxzplrr2
- What is UKCA and UKRP: Tinyurl.com/cus6teyy
- What is an EC REP: https://tinyurl.com/59durub8

Follow me on YouTube @QRA Medical

Follow my Podcast @The MedTech Podcast: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3

As a Medical Device Clinical Research Expert at Rianne Tooten, I provide training, consultancy, and interim support on the implementation of the Medical Device Regulation (MDR) ISO14155 and ISO20916 for manufacturers and clinical research- and healthcare professionals. My mission is to help my clients navigate the complex and evolving regulatory landscape and ensure the quality and safety of their medical device clinical investigations.

With over 15 years of all-round CRA experience and over 10 years of CSM experience in various therapeutic areas and study types, I have a solid background and expertise in medical device clinical research. I am also a member of the Medical Device Working Group at EUCROF and a Medical Device Expert at the Medical Research Ethics Committee UMCG, where I contribute to the development and dissemination of best practices and standards in the field. I am passionate about learning, sharing, and inspiring others, and I strive to deliver high-quality results and solutions that meet the needs and expectations of my clients and stakeholders.

Medical Device Clinical Research Expert services include:
👉In-Depth ISO14155:2020 e-learning (90% pass exam success rate), Medical Device Regulation (MDR), ICH-GCP and ISO20916:2019 training
👉Consultancy on the interpretation and implementation of the MDR and ISO14155 in medical device clinical investigations
👉Interim support on medical device clinical investigations (CSM, CPM, (L)CRA, CTA)

Side projects:
👉Medical device expert at Medical Research Ethics Committee UMCG (NL)
👉Medical device expert at EUCROF

Experience:
Over 15 years documented allround CRA experience (CRO and Sponsor):
Involved in national and international projects for international Sponsors. Experience in medical devices, foods for special medical purposes (FSMP) and baby food as well as pharmaceuticals.

Over 10 years of documented experience in study management of several studies (NL, European, US; Sponsored and Investigator Initiated) in FSMP and medical devices.

Therapeutic areas:
📍orthopedics & cardiology & dentistry (medical devices)
📍diabetes & Dysplastic Colorectal Cancer (pharma & Medical devices)
📍IBD (Pharma)
📍Alzheimer's disease (FSMP)
📍Regurgitation (baby food)

Specialities:
🔸Helicopter view as well as detail oriented
🔸Stakeholder engagement
🔸Presenting
🔸Providing training
🔸Networking
🔸Inspiring + motivating others
🔸Organized
🔸Quality
🔸People person

Member of NVFG, DCRFN, ACRON, EUCROF

Medical Device expert specializing in development of efficient Quality Systems for small and startup medical device companies. As President of Rook Quality Systems, Mr. Rose works as a contract Quality Manager for multiple medical device companies, overseeing overall quality strategy, and ensuring compliance through documentation and auditing services. Mr. Rose is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets, including FDA, CE Mark, Health Canada, and CFDA. Mr. Rose encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QS design.

Specialties: Quality System Development, ISO 13485, 21 CFR 820, ISO 14971, 510(k) submission, Design Control, Risk Management, CE Mark, Greenlight.Guru, Medical Device Software Validation, Product Development, Internal and Supplier Audits, CAPA, Complaint Handling, Supplier Approval, Verification and Validation.

Bio Coming Soon