Experience in R&D, Manufacturing and Testing, Conformity Assessment Activities as a Notified Body Reviewer and Auditor, and finally preparation of Standards and Guidance Documents. 

I support medical device and in-vitro diagnostic device manufacturers preparing and executing a compliant regulatory, clinical and quality strategy in the EU. I can speak the language of legislators, notified bodies and manufacturers. Let´s connect: bassil.akra@akrateam.com

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)
- Medtech (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, Mastercontrol)
- Certified ISO 13485 QMS Auditor (CQI/IRCA)
- Certified EU MDR Practitioner (CQI/IRCA)
- UKCA, CE, FDA, 510k, PMA, De Novo

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

Passionate researcher, mutual success driven reliable business partner.
Medical devices: wearables, home care environment active and diagnostic devices.

▸ Ph.D. from DTU Electrical Engineering (Photonics)

▸ Co-founder and CTO of OptoCeutics: A DTU and UC Berkeley spinoff

▸ Background in physics and engineering from DTU

▸ Published BSc. thesis in a peer-reviewed journal on high-speed holographic resonant later printing. The research project and technology later won the European Innovation Radar prize in Excellent Science, 2018

▸ Research assistant in experimental optics and electro-optics at DTU Nanotech and Fotonik during bachelor and graduate studies

▸ Awarded $3000 for best MSc. thesis and received around 1 million DKK in soft funding allocated to the research project

▸ Co-authored 10+ journal and conference papers

▸ Awarded a Visiting Scholarship at CITRIS, UC Berkeley, California

▸ Studied physics at Rensselaer Polytechnic Institute, USA, as part of my bachelor in 2015

▸ Teaching assistant at DTU for mathematics; volunteer at UNF for mathematics and data science camps

▸ Principal investigator for Optoceutics within the large Marie Skłodowska-Curie ITN EU Project, ASTROTECH, funded by Horizon 2020

▸ Co-supervisor to three Ph.D. students

▸ Secured over 7 million DKK in soft funding; raised over 30 million DKK in equity

▸ Lead on four patent families, co-writing three

▸ Five years of experience in regulatory and clinical affairs for medical device development under MDR 2017/745

“Add value. Inspire Trust.” Our aim is to inspire trust in technology, enabling progress by managing technology-related risks and facilitating change. This commitment is embodied in the new claim: Add value. Inspire trust.

We are a 1 stop technical solutions provider, powered by 150+ years of experience in the safety, security and sustainability business. With 1,000+ locations worldwide and a stable revenue of 2.6 billion Euros, our 25,000+ employees act as process partners to our customers wherever their business is located.

Our team of highly qualified experts audit and certify Quality Managements Systems according to MDR 2017/745, ISO 13485:2016 and other international requirements such as MDSAP, JPAL, CMDCAS. We already conduct Conformity Assessments according to MDR in order to provide our customers with a benefit in a changing and challenging regulatory environment. I am a Team Leader for Active Implantable at TÜV SÜD Product Service and part of this great community.

Experienced Senior Clinical & Scientific Affairs Director with responsibility for the Clinical, Regulatory and Scientific Affairs in Neurescue. ISO13485, ISO14971, ISO14155, GCP US, GCP Auditing & ICH/GCP Certificates.

I have a demonstrated history of working in regulatory and clinical affairs within the medical device industry. Currently in charge of regulatory, clinical, and scientific affairs within Medical Devices and startup companies. FDA submissions (510K and IDE) and MDD/MDR CE mark submission. With a proven record of 510(k) clearance and IDE approvals. Exception from informed consent (EFIC- CRF 50.24) submissions and planning community consultation and public disclosure for EFIC trials in the US. Preclinical investigations (GLP) in Denmark, the US, and France (6 finalized within 3 years resulting in 3 publications). Formative and summative usability studies in Denmark, US, and France. Clinical investigation submissions and approvals from to Ethical Committee and Competent authorities for class IIa, IIb, and III products in EU in emergency medicine according to the MDR.

In charge of developing data safety monitoring committees, clinical trial agreements (including trial budgets), and the development of SOPs and MOPs.

Previously performed clinical post-market studies in Germany, Denmark, and the US (Heidelberg, Copenhagen University Hospital Rigshospitalet, Harvard, Baltimore, Houston Medical Center, Stanford, and Yale).

Cofounder of Medtech Meetup which is a networking group for start-up companies. Mentor for MedTech start-up companies at DTU.

Enrico Perfler is a serial entrepreneur in the medical device industry, and he has accumulated over 20 years of professional experience in the field, particularly specializing in regulatory affairs of medical device technology.

In 2014, Enrico established 1MED SA, an innovative international company that provides a broad spectrum of services including regulatory support, digital solutions, and comprehensive Clinical Research Organization (CRO) services for the medical devices . The company caters to the medical device and in Vitro Diagnostic (IVD) products. Under his leadership, 1MED SA has been at the forefront of overseeing the development and regulatory approval of over 500 medical devices in Europe, thereby cementing Enrico's status as a pivotal figure in the MedTech sector. In 2020, 1MED, under Enrico’s direction as CEO, was recognized among the top 10 medical device life science outsourcing consulting/service companies in Europe.

Enrico's dedication to the industry is further highlighted by his role as a contract professor of "Regulatory Affairs" at the Faculty of Engineering, University of Pavia. His contributions extend beyond academia to significant roles in standardization bodies, including his participation in the ISO/TC 194 technical committee for the biological evaluation of medical devices, showcasing his commitment to advancing industry standards and ensuring the safety and efficacy of medical devices.

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.

M.Sc. in Medical Market Access, EVP Commercial Division at Greenlight Guru. Pall is also the founder of Greenlight Guru Clinical, the only EDC system specifically made for medical devices.

CEO at Qmed-consulting - experts in creating valuebased documentation for innovative medical devices getting access to the markets through strong and honest partnerships with our clients.

It is my vision to enable better health through close collaborations with large established or newly started medical device manufacturers, small venture based innovative companies, venture funds, notified bodies, hospital, doctors and nurses within a wide range of medical device products and concepts from high risk complex products such as heart valves with biological tissue to lower risk class products such as dental care products.

I believe that we through our trusted partners and colleagues can change the treatment of sick patients – making sure frontier products reach the patients and end-users, saving patient lives.

Together with the Qmed team I have provided advice and/or operational services for several clients since 2006 within clinical and regulatory affairs, quality management, reimbursement and health economics and market access with presence through our Qmed team and trusted partners in Europe, US, Canada, India and Australia.

Morven Shearlaw is the Co-Founder and Director of Fearsome, a product design and innovation agency whose mission is to develop insights into actionable innovations, which sharpen their client’s competitive edge and improve the human experience.

Fearsome collaborates with the world’s foremost medical and industrial product companies to supplement or supply their product innovation programme. Areas of expertise include Neurosurgery, Women's Health, Medical Wearables, Optimal User experiences for comfort and Safety and Diagnostics in Healthcare.

Alongside running Fearsome, Morven worked as a Visiting Lecturer in Product Design Engineering with the Final Year student at the Glasgow School of Art. On a more personal note, Morven is involved in a number of volunteering activities primarily towards encouraging the next generation of engineers and wider participation in STEM careers by those currently underrepresented in the industry.

Morven holds a Master of Engineering (MEng), In Product Design and Engineering from the University of Glasgow and Glasgow School of Art. She also holds a Master Degree in Health Ergonomics from the University of Derby.