Insight, Strategy, Results
At MedAssure, we offer affordable yet effective quality assurance and regulatory affairs consulting services within the in-vitro diagnostic and medical device space to take your quality system to the next level and expedite your products to market. Contact me for a free consultation to discuss your project needs today.
Audits
Internal/supplier audit, gap assessment, inspection readiness: ISO 13485, 21 CFR 820, MDSAP, IVDD/MDR, CLIA, GXPs
Regulatory Submissions
510K, PMA, De-Novo, CE-Mark, RoW submissions, liason with regulatory agencies to drive market access.
Quality Management Systems
QMS build-out, gap assessment, remediation, certification. CAPA audit finding resolution (i.e. 483s)
IVDR/MDR
Technical file creation, management, submission. Technical review, Stage 1/2, surveillance audit, product certification.
Software Quality
SaMD architecture, design, test, maintenance, cybersecurity, defect resolution to IEC 62304, 62366, 27001.
eQMS
eQMS migration, training, validation, implementation, maintenance (e.g. Qualio, MasterControl, Trackwise)
About Me
Consummate biotechnology professional and capable people leader with over 12 years of Quality Assurance & Regulatory Affairs experience in the Medical Device and In-Vitro Diagnostic Device space. Highly skilled in adapting to and thriving in dynamic work environments with increasing responsibility.
Subject matter expert in remediation of and building world-class Quality Management Systems compliant with 21 CFR Part 820, ISO 9001:2015, ISO 13485:2016, MDSAP, and IVDR/MDR requirements in a timely manner with minimal resources and supervision. Well-versed in regulatory requirements for key geographies (i.e. USA, EU) and proven track record for obtaining market authorization (i.e. 510K/PMA, CE-Mark), including Technical File creation, management, submission and end-to-end liason with regulatory authorities (i.e. FDA, Notified Body). Seasoned audit veteran in coordinating, hosting, conducting, and passing >100 customer and regulatory audits.
Effective communicator, meticulous critical thinker, and practical problem solver with a quality mindset for bringing innovative products to market to facilitate customer satisfaction and improve patient outcomes.
Testimonials
MedAssure is extremely professional and has been a delight to work with. Jonathan is always thinking 2 steps ahead and goes above and beyond to ensure we were prepared for our FDA inspection.
Jonathan was a life-saver in helping us with the timely remediations of several MDSAP significant audit finding CAPAs to allow us to maintain our product in key geographies and ensure business continutiy.
Extremely knowledgable about the MDR, especially what is needed to make our MDD product portfolio to the new standard. His gift is understanding and presenting the technical details in a compliance manner like a good storyteller!
I worked with Jonathan to migrate our paper-based quality system into an electronic solution. He worked very well independently and collaboratively to ensure we have a sustainable, practical, and compliant solution for years to come.
I was extremely impressed with Jonathan's depth and breadth of knowledge on the IVDR. He knew exactly how to establish post-market surveillance and vigilance system, including registration of our devices in EUDAMED, and implementation of the UDI. We were able to pass our Stage 1 and 2 audits with ease with Jonathan to support us.
Jonathan was instrumental in achieving our quality goals of obtaining ISO 13485. He conducted a thorough gap assessment, developed a detailed quality plan, created/updated over 100 SOPs and forms, and hosted the audit to help us obtain our certification.
FAQ
What certifications do you hold?
ASQ Certified Quality Engineer, ASQ Certified Software Quality Egnineer, ASQ Lean Six Sigma Green Belt, ISO 13485 Lead Auditor (BSI), MDSAP Lead Auditor (Oriel-Stat-a-Matrix), IVDR Lead Auditor (BSI)
How much do you charge?
I offer flexible and competitve rates based on the project scope. I will beat any quote and provide you a detailed timeline with milestones to ensure you meet your goals in a timely and cost-efficient manner.
What types of products have you worked with?
I'm familiar with a variety of products, including Class III (Drug-delivery, Implantable, Combination devices, Surgical sealants), CE-IVD Molecular and Laboratory Diagnostic Systems (Infectious Disease, NIPT, Oncology), SaMD with hardware and AI elements, Blood Collection Devices, Companion Diagnostics, and Cell and Gene Therapies.
What types of companies have you worked with?
I've worked with companies primarily in the Medical Device and IVD space - both big and small, from 1 - 2 person start-ups to international Fortune 50 Biotechs, and with a wide gamut of regulatory obligations, from RUO/academic labs to Class III/GMP design holders and manufacturers.
What is your quality philosophy?
Quality should be, foremost, practical to be effective. I often find companies implement quality systems that are overly burdensome and not user-friendly as there is a lack of understanding of regulatory requirements or as an overreaction to audit findings. Quality is, ultimately, about ensuring products on the market are safe and effective for the end-user. There are multiple ways to get there and I'm here to help you navigate it!
Contact Me
Reach out to me to discuss your project needs today!