Join Regulatory Compliance Associates at the Minneapolis Convention Center in Minneapolis, MN November 2nd and 3rd for MD&M Minneapolis this year. Meet us at booth #3437 to connect with RCA’s EVP of Medical Device and CTO, Seyed Khorashahi. During the conference, Seyed will also be presenting “Security Risk Management Throughout the Medical Device Lifecycle” in the Medtech Security, UI/UX & Digital Transformations track on November 2nd from 10 – 10:45 am.

Seyed has more than 25 years of experience leading R&D teams in all aspects of developing safety-critical medical devices. Seyed has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter, Inc., and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy. 

He also has significant domain expertise not only in FDA and EU standards but also in software systems and hardware development for medical devices. He has a proven track record of efficiently deploying process improvements with extensive knowledge of 21 CFR 820 and ISO 13485.

 


Presentation Title: Security Risk Management Throughout the Medical Device Lifecycle

Abstract: As the need for utilization of AI/ML algorithms for medical devices increases to improve the quality of life of patients so does the need for connectivity and interoperability for these medical devices.  The technologies used to improve the quality of life and user experience of these devices also increase the attack surfaces for potential exploitation by bad actors to harm patients, manufacturers, and health delivery organizations. These cybersecurity vulnerabilities should be identified and mitigated using secure by design principles during the development of the product and security risk managed during the post-market phase of the product lifecycle.

 


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About Advanced Manufacturing and MD&M Minneapolis

The Midwest’s Largest Annual Design and Manufacturing Event

The five-in-one design and manufacturing expo is built to give you a comprehensive view of the product lifecycle—from prototype to production. Explore the latest insights and solutions spanning MedTech, packaging, automation, plastics, and design.

Medtech moves fast… especially in a healthcare hub like Minnesota. Keep pace with the latest innovations and immerse yourself in a community of visionaries and industry leaders. It’s all waiting at the region’s most comprehensive medical design and manufacturing event — MD&M Minneapolis — part of Advanced Manufacturing Minneapolis.

 

About RCA Medical Device Services

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

 

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.

 

Remediation Support

Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.

 

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® Inc.’s worldwide experience can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Regulatory Compliance Associates® Inc. is pleased to announce that our distinguished fellow, Susan Schniepp, has been elected as the Parental Drug Association (PDA) Board of Directors Chair for 2022.

 

The PDA is a recognized authoritative voice and leading technical organization in the field of parenteral science and technology. Through the development of Technical Reports and responses to regulatory initiatives, PDA and its members influence the future course of pharmaceutical products technology.

 

Parental Drug Association

As Chair, Susan will help ensure that the board of directors is effective in its task of setting and implementing the Parental Drug Association direction and strategy and she will provide leadership to the other officers and executives. She was voted in and will begin her duties as the Chair at the start of 2022.

 

We are looking forward to seeing how her influence at the PDA will help advance the industry in 2022.

 

About RCA

Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We 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.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Acquisition strengthens Sotera Health’s quality, regulatory, and technical consulting capabilities

 

CLEVELAND, OH  November 9, 2021 – Sotera Health, a leading global provider of mission-critical sterilization and lab-testing and advisory services announced today that it has acquired Wisconsin-based Regulatory Compliance Associates (RCA). This acquisition expands the US-based quality, regulatory, and technical consulting capabilities of Sotera Health. RCA is an industry leader in providing life sciences consulting focused on quality, regulatory, and technical consulting for the pharmaceutical, medical device and combination device industries. Terms of the deal were not disclosed.

 

Headquartered in Pleasant Prairie, Wisconsin, RCA has extensive industry knowledge through a network of in-house and external experts and is known for its best-in-class solutions. Founded in 2000, the company has grown to be nationally recognized for its tailored, solution-driven approach to compliance related issues.

 

“Regulatory Compliance Associates is a premier provider of quality and regulatory services; known for its best-in-class solutions. It is also recognized for its strong relationships with its customers and regulators,” said Michael B. Petras Jr., Chairman and CEO of Sotera Health. “This acquisition will expand and further strengthen our technical consulting capabilities. We welcome RCA’s strong management and expert staff as they join us in our mission, Safeguarding Global Health®.”

 

“Our mission is to provide our customers with unsurpassed technical expertise combined with quality service. We have earned a reputation for our customer service and are seen as an essential partner for our customers—and we know we have found the same in Sotera Health,” said Erika Porcelli, CEO of RCA. “My goal for RCA is to continue our commitment to serve customers supporting their regulatory and compliance needs as they bring critical pharma and medical device products to market. We accomplish this by becoming part of Sotera Health, a global company whose breadth of services and expansive reach provide extraordinary value to the industries we are proud to serve.”

 

Regulatory Compliance Associates’ consulting capabilities will complement and enhance Sotera Health’s existing strengths in technical consulting and expert advisory services. Regulatory Compliance Associates is ISO 9001 accredited.

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.  Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.  

 

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.

 

About Regulatory Compliance Associates

Regulatory Compliance Associates® Inc. (RCA), is a life sciences consultancy focused on quality, regulatory, and technical consulting headquartered in Pleasant Prairie, Wisconsin with offices in Colorado and Florida.  RCA provides worldwide services for the resolution of compliance and regulatory challenges to the Pharmaceutical, Biologic & Biotechnology, Sterile Compounding, and Medical Device industries.  We understand the complexities of running a life sciences 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.  Achelous Partners provided investment banking and advisory services to RCA in the transaction. Learn more about Regulatory Compliance Associates at https://www.rcainc.com/.

 

Media Contacts:

Sotera Health:                                                                             

Kristin Gibbs                                                                                 

Chief Marketing Officer                                                            

kgibbs@soterahealth.com           

 

Regulatory Compliance Associates:

Erika Porcelli

Chief Executive Officer

E.Porcelli@rcainc.com

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Check out the interview Vice News did with our Executive VP of Pharmaceuticals, Steven Lynn, on how the Covid-19 pandemic is revealing major holes in the pharmaceutical supply chain.

 

About Steve Lynn

Supply ChainSteve has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues.

Joining Regulatory Compliance Associates® Inc. in September of 2020, Steve serves as RCA’s Executive Vice President of Pharmaceuticals.

Prior to joining RCA, Steve served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA. In the private sector, Steve was an executive at two large multi-national corporations and also worked as a compliance and supply chain consultant. He was the Global Head of Group (Corporate) Compliance and Audit for Novartis AG. In this role he led the corporate-level GxP corporate compliance and audit functions across the company.

Next, Steve was the inaugural Vice President of Global Quality Compliance for Mylan, Inc. a large generics manufacturer. Prior to rejoining the private sector, Steve worked for nearly a decade at the FDA. At the FDA, was the Director of the FDA/Center for Drug Evaluation and Research’s (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance (OC). In this role, he was responsible for the global Current Good Manufacturing Practices (CGMP) oversight of all drugs manufactured and/or imported into the United States to assure compliance with CGMPs.

In addition, in his last year at the FDA, he served in a dual position as the Operations Transition Lead for CDER’s new Office of Pharmaceutical Quality (OPQ) reporting to CDER’s Center Director where he was responsible for setting up OPQ operations.

Steve also served in two acting roles on the inspectorate side of FDA within the Office of Regulatory Affairs (ORA). First, he served as the acting Senior Advisor to the Assistant Commissioner for Operations (ACO) within the Immediate Office of ORA’s Office of Operations. In this role, Steve was responsible for advising the ACO in their role of leading and managing ORA’s Office of Operations, which is responsible for all of the Agency’s Headquarters, Domestic and Foreign Field Investigatory, Compliance, and Laboratory Operations.

Second, Steve served as the acting Director for ORA’s Office of Medical Products and Tobacco Operations (OMPTO). In this role, Steve represented and made decisions on behalf of the ACO relating to medical and tobacco product program investigatory operational issues, including emergency response activities and supply chain. In addition, he directed the coordination and management of all domestic and foreign Agency field operations related to medical (drugs, biologics, and medical devices) and tobacco products. Additionally, Steve served as the operational liaison for medical products and tobacco inspection programs to FDA’s medical product and tobacco Centers, as well as to the Agency’s foreign offices.

Steve received a Bachelor of Science degree in Biology from Bethany College in Bethany, WV, and a Master of Science Degree in Quality Systems Management from the National Graduate School in Falmouth, MA. He is an Eagle Scout, Senior Member of the American Society for Quality (ASQ), and an Excellence in Government Program Senior Fellow.

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We 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.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Pleasant Prairie, WI (Sept 22, 2020) – Regulatory Compliance Associates® Inc. (RCA), a life sciences consultancy focused on quality, regulatory, and technical consulting, announces Steven Lynn has accepted the position of Executive Vice President of Pharmaceuticals.

 

Mr. Lynn brings more than  20 years of global, real-world experience in the private sector and U.S. federal government, including two U.S. Food and Drug Administration product Centers (the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health), as well as FDA’s inspectorate (the Office of Regulatory Affairs).  “RCA clients will benefit from Steve’s expertise with FDA’s insights regarding compliance and regulatory framework and will help them navigate regulatory challenges in the medical product and biologics sectors,” says Erika Porcelli, CEO of RCA.

 

In addition to his FDA experience, Steve gained valuable real-world, private sector experience in global manufacturing and quality for generics and brand pharmaceuticals, as well as in the medical device industry. Prior to joining RCA, Steve held executive roles with leading brand and generic pharmaceutical and biopharma manufacturers, the FDA, and in private consulting in the areas of pre and post-market (GxP) quality, compliance, and regulatory affairs.  “His extensive background spanning industry, consulting and the FDA gives Mr. Lynn a unique perspective in providing RCA clients with wholistic and seasoned guidance as they bring new life-sustaining medicines to the market, as well as maintaining compliance with FDA and other global health authorities quality oversight,” adds Porcelli.

 

Accomplished in leadership and quality management, Steve earned a Master of Science degree in Quality Systems Management from the National Graduate School of Quality Management (NGS), is a Senior Fellow in Study Excellence in the Excellence in Government Leadership Program, and has a Bachelor of Science degree in Biology.  Mr. Lynn also served the non-profit Parenteral Drug Association (PDA) as the Secretary of the Board.

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We 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.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

PLEASANT PRAIRIE, Wis.Nov. 25, 2019 – Regulatory Compliance Associates® Inc. (RCA), a life sciences consultancy focused on quality, regulatory, and technical consulting, announces Erika Porcelli has accepted the position of Chief Executive Officer.

 

“Bringing more than 20 years’ experience in relationship building, Erika’s focus for 2020 is centered on the customer experience,” said Board Chairman, Mitch Januszewski. “Erika brings a wealth of experience and energy to the company. We are looking forward to Erika’s client-focused leadership and the roll-out of client-centric initiatives in the new year.”

 

“More than ever before, we will be focusing on building relationships and putting our clients first,” said Porcelli. “We will be introducing new tools and processes to both streamline and deepen our client communications and ensure we’re consistently delivering the greatest value.” Having touched all aspects of RCA services, it’s these relationship-driven interactions that Porcelli values most.

 

Prior to her role as CEO, Erika Porcelli served as Senior Director of Business Development for RCA’s northern U.S. territory and, most recently, Vice President of Client Relations. She brings her extensive knowledge in marketing programs, analysis and market research, marketing communications, and sales process opportunities, as well as in-depth knowledge of the pharmaceutical, biotech, and medical device industries.

 

Additionally, she has expertise in new business development, contract negotiation, and budget management. Erika Porcelli is also the host of RCA’s podcast, RCA Radio, which launched in June 2019.

 

Erika Porcelli

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We 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.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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