Meet the Awesome Medical Device Team at Compliance Architects

At Compliance Architects LLC, we don’t just provide top-notch quality compliance solutions; we celebrate the people who make these services possible. Our team is the heart of our success, and today, we’re excited to introduce you to some exceptional individuals who bring their expertise to the medical device industry. Let’s dive in and get to know the medical device team at Compliance Architects better!

Highlighting Our Medical Device Team Experts

Teresa Gorecki

Teresa Gorecki is our VP and Practice Lead. With over 30 years of experience in all areas of Quality Assurance (GLP, GCP, GMP, QSR, Part 4, Part 11, etc.), Teresa has been an Executive Quality Consultant for over eight years. She held senior executive leadership roles at Johnson & Johnson for over 15 years. She has extensive experience with medical devices and biopharma, including cell and gene therapy, pharma, and consumer products.

Teresa has led the FDA approval of numerous products, including monoclonal antibodies, r-DNA products, complex combination products, and medical devices. Her consulting experience extends to RadioPharmaceuticals and Companion Diagnostics, applying regulations and guidelines to novel products. Teresa supports virtual start-up companies in BioPharma and Novel Pharma, creating risk-based quality management systems suitable for clinical development phases.

Teresa has deep experience managing FDA inspections, preparing 483 and Warning Letter Responses, and conducting pre-approval inspections. She develops quality and compliance strategies to prevent the issuance of Warning Letters or DOJ referrals and ensures transparent communication with the FDA.

You can learn more about Teresa here.

John Daley

John Daley has over 30 years of experience in FDA-regulated industries. He has remediated Warning Letters, Probation agreements, and integrated billion-dollar acquisitions. John has worked with global companies and small start-ups, handling all classes of devices both in the US and globally. He has significant experience with combination products, In-vitro Diagnostics, and pharmaceuticals.

John has been on leadership teams, resolving probation agreements and corporate warning letters. His extensive management experience with companies like Johnson & Johnson, Boston Scientific, and IBM showcases his ability to deliver value and grow as a leader. John is known for his high standards of excellence, curiosity, and ability to attract and retain great people.

You can learn more about John here.

Pedro Martinez

Pedro Martinez, a native of Juana Díaz, Puerto Rico, holds a bachelor’s degree in Chemical Engineering from Clarkson University. He has experience in Process Development, Quality, and Manufacturing in the chemical and Pharmaceutical Industries, where he managed facilities specializing in active pharmaceutical ingredients. He later moved into the medical device arena, developing and commercializing new technologies for minimally invasive surgeries.

Pedro set up the first global manufacturing facility for the first commercially sold Drug-Eluting Stent. He also worked as a Management Consultant with the Gallup Management Organization, specializing in Employee Selection, Organizational Engagement, and Customer Retention. Pedro pursued further education, including an MBA in Management, a Master’s in Finance, and advanced programs at Northwestern University and Purdue University. He is a Registered Professional Engineer and a Johnson & Johnson Certified Black Belt.

You can learn more about Pedro here.

Our Services in the Medical Device Space

Now that you’ve met some fantastic team members, let’s discuss what we do. At Compliance Architects LLC, we offer a wide range of services tailored to meet the unique needs of the medical device industry. Here’s how we can help:

• FDA Inspection Readiness: Preparing your organization for FDA inspections, including QSR, For Cause, PMA, MDSAP, and Notified Body inspections.
• Audits & Assessments: Comprehensive audits and assessments to identify areas for improvement and ensure compliance.
• FDA Enforcement Response/Remediation: Assistance with 483 Response preparation, Warning Letter Response preparation, 3rd Party Compliance Oversight, and Consent Decrees.
• Quality System & Compliance Remediation and Improvement: Improving and remediating your quality systems to meet regulatory requirements and industry best practices.
• Quality System Design and Development: Designing and developing robust quality systems tailored to your specific needs.
• Bespoke Training / Coaching: Personalized training and coaching to enhance your team’s knowledge and skills.
• Quality & Compliance Computer-Based Systems: Selection and validation support for quality and compliance computer-based systems.
• Oversight of Third-Party Suppliers and Contract Manufacturers: Ensure third-party suppliers and contract manufacturers meet your quality standards.
• Part 11 & Computer Systems Validation: Ensuring your computer systems comply with Part 11 regulations and are properly validated.
• Data Integrity Assessments and Remediation Planning and Execution: Assessing and remediating data integrity issues to ensure data reliability and accuracy.
• Quality Engineering and Process Excellence Expertise: Guidance on quality engineering and process excellence to improve operations.
• Quality Culture Assessment: Assess your organization’s quality culture and provide recommendations for improvement.
• Product Quality Consulting: Expert advice on maintaining and improving product quality.
• Project/Program Management: Providing project and program management services to help you achieve your goals efficiently.
• Device Design Assessment and Remediation: Assessing and remediating device design issues to ensure compliance and functionality.
• Risk Management: Identifying, assessing, and mitigating risks in your processes and products.
• Development of Remediation Strategy: Developing and implementing effective remediation strategies.
• Support of FDA Regulatory Meetings, Correspondence, and Interactions: We will support you in FDA regulatory meetings, correspondence, and interactions.
• EUMDR Assessment and Implementation: Assisting with EUMDR assessment and implementation.
• IVDR Assessment and Implementation: Supporting IVDR assessment and implementation.
• Support of Quality System Development and Implementation for Precision Medicine: Supporting the development and implementation of quality systems tailored to precision medicine.

Industries We Support

We proudly support a diverse range of industries, including:

• Medical Devices and Diagnostics
• Combination Products
• Pharmaceuticals
• Biopharmaceuticals
• Cell & Gene Therapies
• Consumer Products (OTCs, Cosmetics, and Class 1 Devices)
• Cosmetics
• Dietary Supplements

Client Testimonials

Here’s what some of our clients have to say about us:

• “The CA approach is unique; they believe ‘actions speak louder than words.’”
• “They designed risk-based solutions that are right-sized for our business. They are not ‘over-engineered.’ They developed process-based quality systems integrated into our business processes.”
• “They left us stronger than when they arrived. We are not ‘consultant dependent.’”
• “They are not just in the business of advising or identifying gaps; they DO work. They prioritize and provide laser focus on the things that make a difference. Instead of driving 30 small CAPAs, we focused on the ‘BIG FIX’ to secure a successful Pre-Approval Inspection by FDA.”
• “They understand what FDA expects; helped us understand where we were deficient and prevented a Warning Letter.”
• “They provided a beacon of light when our company was in utter darkness. We had received our third Warning Letter in seven years… they moved us away from further action with FDA and into the light. They helped save our company.”
• “They left me with a roadmap I could follow and that we were ABLE to follow.”

If you’re looking for expert guidance in the medical device industry, look no further than Compliance Architects LLC. Contact us today to learn more about our medical device team and how we can support your business needs.