RCA Radio

In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanir Ali of BSI to unpack the evolving landscape of cybersecurity in medical devices. Together, they explore the latest FDA and EU guidance, the growing expectations for connected device security, and the top gaps companies face when bringing products to market. From threat modeling and SBOMs to legacy device challenges and global regulatory alignment, this episode offers practical insights for MedTech developers navigating today’s complex cybersecurity requirements. Whether you're launching a new device or updating an existing one, this conversation is packed with actionable advice to help you stay secure and compliant. 

In this episode of RCA Radio, host Brandon Miller sits down with Jessica Schafersman, a design and development expert at RCA®, to break down the increasingly complex world of combination products—those that blend drugs, devices, or biologics. Jessica shares insights on why these products are uniquely challenging, the regulatory expectations companies must meet, and how the FDA guidance that is intended to make the submission process streamlined. From design controls and quality system integration to the importance of human factors validation and international considerations, this episode is packed with practical advice for any company entering or expanding in the combination product space. 

In this episode of RCA Radio, host Brandon Miller is joined by RCA experts Anita Michael and Arie Anahory for a deep dive into the evolving world of compounding pharmacies. Together, they explore the critical role compounders play in personalized medicine, their differences from traditional pharmaceutical manufacturers, and the increasing regulatory scrutiny they face—especially 503B outsourcing facilities.The discussion covers:The origins and types of compounding pharmacies (503A vs. 503B)Regulatory challenges post-New England Compounding Center crisisKey compliance hurdles including aseptic processing and FDA inspectionsPractical advice for both new and established compounders to stay compliantWhether you're entering the compounding space or navigating the latest compliance expectations, this episode offers timely insights and actionable guidance.

 In this episode of RCA Radio®, host Brandon Miller is joined by Rod Mell, Executive Head – Life Science Consulting at RCA, as well as Jordan Elder, Director of Regulatory both at Regulatory Compliance Associates. We explore possible changes in the Medical Device industry in 2025 and provide you with insight on how to prepare yourself for these upcoming initiatives.Listen in as we go over updated EU MDR / EUDAMED timelines, recent and upcoming final guidance documents, the strategic priorities outlined by the FDA, the Quality Management System Regulation (QMSR Final Rule), the agency inspection focuses, and how companies can prepare themselves for success with the incoming changes. About RCARegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

In this episode of RCA Radio®, host Brandon Miller is joined by Anita Michael, Executive Pharma Compliance Expert & Principal Consultant and Rona LeBlanc-Rivera, Director, Regulatory Affairs both at Regulatory Compliance Associates®.  We explore possible changes in the Pharmaceutical industry in 2025 and provide you with insight on how to prepare yourself for these upcoming initiatives.Listen in as we go over the expected reduction in the FDA's work force, recently executed guidance documents, regulatory timelines, drug labeling transparency, the broadening scope of OTC products, the use of AI in the regulatory review, and how companies can use 3rd party inspections to help prepare themselves. About RCARegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

In this episode of RCA Radio, host Brandon Miller is joined by Nelson Labs Director of E&L Raymond Colton as well as board certified toxicologist Dr. Sarah Campbell also from Nelson Labs to discuss the recent draft FDA GUIDANCE DOCUMENT: Chemical Analysis for Biocompatibility Assessment of Medical Devices.Listen in as we cover why this guidance why is important, the potential impacts of this guidance to device manufactures, and some best practices Nelson Labs testing facilities are already implementing to insure a smooth transition once this is published. We discuss things like changes to current chemical characterization approaches as possible leeway that could be given depending on the product.

In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Regulatory Compliance Associates'® (RCA) Regulatory Expert. Kinga Demetriou, an Expert Certifier at BSI, and Nathan Shipley, a Global Certification Manager at BSI to discuss the current trends and challenges with Regulatory Requirements US and EU while focusing on personal protective equipment.Listen in as we cover the current trends in the industry, the challenges companies face in relation to the trends, and how companies can address and prepare in this evolving landscape. We cover things like market access, product category changes, as well audience diversification with personal protective equipment (PPE), and why the regulatory requirements are changing in these areas. About BSIBSI enables people and organizations to perform better. They share knowledge, innovation and best practice to make excellence a habit – all over the world, every day. Their solutions and services improve performance and support the United Nations Sustainable Development Goals. At BSI, our mission is to share knowledge, innovation and best practice to help people and organizations make excellence a habit. This is underpinned by our role as the national standards body and through our prestigious Royal Charter. About Regulatory Compliance AssociatesRegulatory Compliance Associates (RCA) provides regulatory compliance consulting to the following industries:Life SciencesPharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceLab TestingWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.Founded in 2000Expertise backed by over 500 industry subject matter expertsAcquired by Sotera Health in 2021

In this episode of RCA Radio, host Brandon Miller is joined by Eric Januszewski, Senior Director of Client Relations for US and Europe, at Regulatory Compliance Associates® (RCA) to talk about outsourced technical program management and the increased demand caused by the shortage of qualified subject matter experts.Listen in as Eric goes over what outsourced program management is, the benefits clients receive when having a technical program manager, and the heuristic approach RCA takes with their program managers to transfer knowledge to the clients internal team. About RCARegulatory Compliance Associates®  (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceLab TestingWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 In this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Susan Schniepp explore what is happening in the Pharmaceutical industry in 2023 and provide you with insight on how to prepare yourself for these upcoming initiatives. Steve is Regulatory Compliance Associates®  (RCA) Executive Pharmaceutical Consultant and Susan is the chair of PDA and as well as a Distinguished Fellow at RCA. Listen in as we go over the increase in spending in the industry as a whole, the continued expansion of cell and gene therapies, drug and device combination products for home and office use, cybersecurity in combination products, non-life science company’s getting into the pharma industry, data integrity and compliance issues, vaccine development with the expansion of mRNA technologies, the post pandemic shift of 503b compounders, and finally the cultural shift around retiring. About RCARegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

In this episode of RCA Radio, host Brandon Miller is joined by Jessica Schafersman, Biomedical Engineer, Project Management Professional, and Certified Usability Analyst at Regulatory Compliance Associates® (RCA) to talk about Design controls and the proper way to go about developing your DHF for your Medical Device products.Jessica has over 20 years of experience in medical product development. She started her career in a medical device startup, working directly with physicians and end users to develop a bleeding edge surgery system. Since then, her work experience has spanned combination products, sterile implants, sterile disposables, capital equipment, and instrumentation at all phases of development. She is currently one of RCA’s Quality subject matter experts in helping clients create and improve their design history files as well as the entire Quality Management System.Listen in as Jessica goes over the trends we as consultants are seeing, how experts can help in the process, the first steps in getting the right help, and finish off with some major pitfalls clients face during the DHF process.About RCARegulatory Compliance Associates®  (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceLab TestingWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.