ISO 13485 Consulting for the Medical Device Industry
We stay with you until you pass. No matter what.
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Get Your ISO 13485 Certification Program for Medical Devices Written, Implemented, and Certified Quickly
ISO 13485 is an international standard published by the International Organization for Standardization (ISO) for medical device quality management systems (qms).
Kellerman Consulting is an ISO 9001:2015 certified consulting company and we have assisted 800+ clients throughout the supply chain to get their ISO certification programs written, implemented and certified. Kellerman Consulting has full-time employees on staff (bilingual English/Spanish available) who have taken ISO 13485 certification training and have worked in the medical device industry.
Our ISO 13485 consulting process is effective because we stay with you until you pass. No matter what.
What to Expect During Your ISO 13485 Consultation
During your free ISO 13485 consultation, you’ll learn what the requirements are for getting certified, how much it costs with no hidden fees, how long it takes, and how our process works to assure you pass your ISO 13485 certification audit on the first try.
Our ISO 13485 Consulting Process Delivers a 4X Faster Turnaround and a 100% Success Rate
How do we do it? By working closely with your team and by following our repeatable and reliable ISO 13485 consulting process to help get your medical device business ISO 13485 certified. We will write and implement your ISO 13485 QMS and tailor policies and procedures to your satisfaction and to meet certification standards.
Our ISO 13485 Consultants Deliver
Consistent ISO 13485 Certification Results to Grow Your Core Medical Device Business
All of our ISO 13485 consultants are full-time employees and are well-versed in Kellerman Consulting’s repeatable and reliable ISO 13485 process for your medical device industry business. Our team’s collaborative culture gives you the benefit of our collective experience with hundreds of successful outcomes. You will achieve the same 100% success rate regardless of which of our team members you work with.
Quality Control and Accountability to Meet Certification Standards
You benefit from the support of ISO 13485 consultants who review every project as a team. Kellerman Consulting’s Senior Management team members are involved with each project at every stage to make sure that our consultancy is delivering on our commitment to our clients and ensuring customer satisfaction. Protect and develop your core business with support from our ISO 13485 consulting team.
Responsiveness
Our full-time ISO 13485 consultants respond immediately to all client questions, which reflects one of our core values. Kellerman Consulting team members are kept up to date on every project, so that any one of our consultants can easily step in at any moment to give you the reliability and responsiveness your project deserves.
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We’ll assess your unique process and ISO needs.
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Our team will write your ISO 13485 quality management standard program customized to your organization and your device.
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We’ll train you and your team on how to follow all of the ISO quality management system procedures.
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Implement your ISO program with our ISO consultant right beside you.
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Pass your ISO audit with support from our team.
ISO 13485 Q&A:
What is ISO Certification?
ISO certification is a voluntary certification process to verify if a service, product, or system meets the standard requirements of the International Organization for Standardization (ISO).
What Types of Companies Get ISO 13485 Certified?
Companies who get ISO 13485 certified are part of the design, production, installation, storage, development, and servicing of medical devices. Businesses which manufacture medical devices or supply services to medical device manufacturers often choose to get ISO 13485 certified in order to ensure the quality of products and services. ISO 13485 certification is a well-recognized international certification standard that is specific to the medical device industry.
How is the Medical Device Industry Regulated in the United States?
The Food and Drug Administration (FDA) regulates the medical device industry in the United States. Medical device manufacturers must seek FDA approval by showing evidence that a device is safe and effective before a medical device can be sold in the United States.
What is the Difference Between ISO 13485 and FDA Part 820?
ISO 13485 is an international standard, and 21 CFR Part 820 is specific to the United States. 21 CFR Part 820 is mandatory in the United States and it is required for medical device distribution in the United States, whereas ISO 13485 is a voluntary certification scheme.
In January of 2024, the FDA published a final rule to align its Quality System Regulation (QSR) with ISO 13485. The updated FDA part 820, called the QMSR will be effective Feb. 2, 2026.
Is ISO 13485 Mandatory?
ISO 13485 certification is not mandatory, however, retailers and businesses in the medical device supply chain may require companies to be ISO 13485 certified prior to doing business together.
Our ISO 13485 Quality Management Services
We create custom ISO projects for every organization we serve. Our ISO consultants provide support services for improved business processes and quality management procedures.
About Kellerman Consulting
Kellerman Consulting, a family-owned, food safety consulting and ISO consulting company, has achieved ISO 9001:2015 certification for our Quality Management System, and Exemplar Global Recognized Consulting Group (RCG) designation, demonstrating our deep commitment to delivering high quality services to our clients. At Kellerman Consulting, our team of food safety, quality & ISO consultants have helped 800+ clients nationwide to write and implement their food safety certification programs and ISO certification programs and pass their audits on the first try. All of our consultants are full-time employees and are well-versed in Kellerman Consulting’s repeatable and reliable process. You will achieve the same successful outcome regardless of which of our team members you work with.
Our Team Certifications
Registered SQF Consultants |BRCGS |FSSC 22000 | PrimusGFS | ISO 13485 | ISO 14001 | ISO 45001 | AS9100 | ISO 19011 | Internal Auditing | PCQI for Human Food and Animal Food |FSVP |USDA HACCP |Seafood HACCP | Juice HACCP | Better Process Control School | Registered Sanitarian | ServSafe | AFDO Process Authority
Our Team
Brian Kellerman
Chief Quality & Food Safety Officer
As the Chief Food Safety & Quality Officer of Kellerman Consulting, Brian is dedicated to assisting businesses with their food safety and quality programs and supporting all of the consultants at Kellerman Consulting to assure that each client project leads to a successful outcome.
Since 2016, Brian has written & helped implement hundreds of food safety & quality management system programs for clients nationwide. Brian stays with our clients until they pass their certification audits and compliance inspections – no matter what.
Brian has taken the lead at Kellerman Consulting with guiding and helping to implement our most technically complex client projects. He expertly creates food safety and quality programs tailored to our clients’ unique processes. Brian has helped our clients pass audits that integrate requirements from multiple certification schemes into one program, such as combined ISO 9001 programs with BRCGS or SQF and Forest Stewardship Council (FSC).
Brian has completed certifications and holds qualifications including: Registered SQF Consultant, Exemplar Global Certified Management System Implementation Consultant, ISO 9001:2015 Internal Auditor, ISO 45001:2018 Internal Auditor, ISO 14001:2015 Internal Auditor, ISO 19011:2018 Auditing Module, FSSC 22000, BRCGS, AFDO Process Authority, Preventive Controls for Human Food, Preventive Controls for Animal Food, Seafood HACCP, Juice HACCP, Better Process Control School for Low Acid, Acidified Foods, and Aseptically Processed Foods
Brian graduated with a degree in Ecological Agriculture from the University of Vermont and then became the head of the science department at a high school while teaching Biology & Chemistry. Starting in 2013, Brian worked in quality assurance and managed a BRCGS program for a facility that produced over 5 million pounds of dry spice blends, pet food, and dietary supplements until 2016, when he and his brother Mickey started Kellerman Consulting.
Mickey Kellerman
President
As President of Kellerman Consulting, Mickey gets to live his passion of helping others each and every day. He is responsible for leading sales, marketing, finance, administration and strategy for Kellerman Consulting, as well as providing support to his incredible team and to countless food safety and quality professionals and business owners nationwide.
Mickey comes from a family of entrepreneurs, and in 2016 he teamed up with his brother Brian to found Kellerman Consulting. The very first thing Brian and Mickey did when planning to start up Kellerman Consulting was to set the core values of the company to be honesty, transparency, accountability, responsiveness, supportiveness and relentlessness. Those values are the foundation of Kellerman Consulting and have remained the same since its founding.
Since 2016, Kellerman Consulting has completed over 800 successful client projects and followed through on their commitment to provide free food safety and quality training videos and educational resources for companies throughout the supply chain.
Mickey has a Bachelor of Science in Industrial Engineering from Northwestern University and has 20+ years experience in various leadership roles in the food industry, financial sector, manufacturing sector and music industry. His other passions include cooking, hiking, meditating, writing music, playing synthesizer, seeing live music and spending time with friends and family.
Laura Swanson
Food Safety & Quality Consultant
Registered SQF Consultant
Laura Swanson joined the Kellerman Consulting team in 2022 as a Food Safety and Quality Consultant. With nearly two decades of experience and over a decade of working with GFSI systems and quality management systems specifically, Laura has a passion to help our clients navigate the world of food safety and quality. Laura obtained her Masters in Food Science and Technology from Oregon State University.
Laura currently holds the following certifications and qualifications:
- AS9100D – Internal Auditor (for the Aerospace and Defense Industry)
- ISO 9001:2015 Internal Auditor / Lead Auditor
- Registered SQF Consultant
- Seafood HACCP
- Juice HACCP
- FSPCA Internal Audit Mitigation Strategies
- FSPCA Key Activity Types
- FSPCA Preventive Controls for Human Food
- FSPCA Foreign Supplier Verification Programs
- Pathogen Environmental Monitoring Programs
- Better Process Controls School
- FSPCA Food Defense Awareness
- SQF Implementation
Throughout her career, Laura has had the opportunity to work with multiple facilities to achieve their first SQF certifications and Quality Management system certifications. Other audit standards she has worked with include BRC, USDA Organic, Non-GMO Project, Marine Stewardship Council, Interstate Shellfish Sanitation Conference, and Gluten Free certifications. Laura also has the unique experience of project managing facility builds.
When Laura is not serving our clients, she spends her time adventuring with her husband and two sons riding bikes, hiking, camping, and exploring.
Alvaro Falquez
Food Safety & Quality Consultant
Alvaro Falquez is an accomplished bilingual (English/Spanish) Food Safety and Quality professional with a Bachelor’s Degree in Food Science & Technology and a Master’s Degree in Business Administration. Since 1997, Alvaro joined the Food Industry, starting with developing HACCP Programs for seafood packaging companies and later for a Bulk Coffee Exporting Company.
With a solid foundation in operational roles, Alvaro returned to his core expertise in Food Safety & Quality in 2006. His career has since been marked by his management of USDA- Quality Assurance Programs (QAP), BRC Certifications, FSSC 22000 Systems, Integrated ISO schemes (including ISO:2015, 14001:2015, & 45001:2018), and other standards. Alvaro has also helped businesses achieve SQF and Organic Plant Certifications from inception.
Alvaro’s expertise in problem-solving and value stream design has significantly impacted cultural and operational transformations at leading Consumer Packaged Goods (CPG) companies. His broad experience across multiple sites includes improving Key Performance Indicators (KPIs), ensuring regulatory compliance, conducting CIP assessments and validations, overseeing microbiology lab operations, and leading line expansion projects, among other responsibilities, in both startup and high-speed environments.
He believes in three core principles for organizational success; goal alignment, high ambition, and capability building. Alvaro is committed to ensuring that these principles guide his approach; fostering sustainable results and continuous improvement.
He holds several certifications that reflect his expertise and commitment to excellence in the field:
- SQF Certification
- Juice HACCP Certification
- PCQI Certification
- FSSC 22000 Certification
- ISO 19011:2018 Internal Auditor Certification
- Integrated ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018 Internal Auditor Training
Outside of his professional endeavors, Alvaro is passionate about cycling, playing tennis, watching international soccer leagues, and traveling with his family.
Tim Grady
Food Safety & Quality Consultant
Registered SQF Consultant
After obtaining a B.S. in Environmental Science and a B.S. in Regional Planning in 2015, Tim gained food safety compliance experience as a health inspector. Tim joined the Kellerman Consulting team in 2019 to pursue a career in food safety and ISO technical writing and consulting.
While at Kellerman Consulting, Tim has been the lead consultant assigned to write and implement food safety and quality management system programs for over 60 clients of diverse types.
In recent years, Tim has taken a special interest in becoming an expert on ISO and helping our clients to write and implement ISO programs for their businesses including Printing, Packaging, Part Fabrication, Engineered Parts Sourcing, and more.
Tim has also completed the following qualifications and certifications: Registered SQF Consultant, PCQI, Seafood HACCP, Internal Auditing, ISO:2015 Certified Lead Auditor, Registered Environmental Health Specialist (Ohio), Registered Environmental Health Specialist (NEHA)
Tim has expertise in the following:
- Repackaging of Products not Manufactured on Site
- Storage and Distribution
- Manufacture of Food Packaging
- Manufacture of Dietary Supplements
- ISO Quality Management Systems
- Forest Stewardship Council (FSC)
- FSVP
- FSMA
- HACCP
- Food Ingredient Manufacturing
- Recipe Meals Manufacturing
- Processing of Cereal Grains
- Slaughtering, Boning and Butchery
- Manufactured Meats and Poultry
- Seafood Processing
- Dairy Food Processing
- Bakery and Snack Food Processing
- Fruit, Vegetable, and Nut Processing, and Fruit Juices
- Ice, Drink and Beverage Processing
- Confectionery Manufacturing
- Preserved Foods Manufacturing
- Food Catering and Foodservice
- Food Retailing
When not at work, Tim enjoys playing disc golf, collecting comic books and passionately rooting for all New England sports teams.
Carissa Marzouk
Food Safety & Quality Consultant
Registered SQF Consultant
Carissa has a strong passion for food safety and quality. She has experience working in startup
environments and has helped these teams build their food safety programs from the ground up.
She has worked with teams to achieve their first ever food safety and SQF certifications and knows what it takes to maintain those certifications. She has served as a PCQI in her previous roles and enjoys working cross-functionally to build and improve food safety programs and foster a positive food safety culture.
Carissa obtained a B.S. in Biology from Saint Mary’s College of California and has completed the
following food safety certifications: FSPCA Preventive Controls for Human Food, Implementing SQF Systems, Advanced HACCP, and Juice HACCP.
In her free time, Carissa enjoys cooking and spending time with her husband and pets.
Shannon Wilson
Food Safety & Quality Consultant
Registered SQF Consultant
Shannon joined the Kellerman Consulting team in 2024 with a desire to promote continuous improvement and positive food safety culture throughout the food industry. Previously in her career, she has had the opportunity to work at several different CPG facilities in a variety of food categories, including: produce, deli, confectionery, snacks, and beverage.
Shannon obtained a Bachelors in Food Science and a Minor in Communication from the University of Florida and holds the following certifications:
- Registered SQF Consultant
- FSPCA Preventive Controls for Human Food – PCQI
- Implementing SQF System: Food Safety for Manufacturing
- Implementing SQF System: Quality
- Certified Professional Food Manager
Shannon prides herself on having a hands-on approach and loves to work hard, collaborate, and deliver results. She loves to be part of a team that takes pride in their work and values their efforts having a meaningful impact on the business and its community.
When Shannon is not working with clients, she spends her time adventuring, cooking and baking, and planning her next trip!
Phoebe Kellerman
Business Support Manager
As a Business Support Manager for Kellerman Consulting, Phoebe Kellerman is responsible for many of the behind-the-scenes activities that allow our consulting team to focus their time and energy on solving our clients’ toughest food safety problems. Coming from a family of professional chefs and bakers, Phoebe learned the importance of food safety and quality assurance at a young age.
Before joining Kellerman Consulting, Phoebe spent thirteen years as a Licensed Clinical Social Worker and Supervisor. In her position, she managed a team of interdisciplinary team members as well as provided administrative support and professional development as necessary for the success and growth of her team. Since her previous position also included networking with community agencies to ensure coordination of care and quality assurance, Phoebe sees this as a flawless transition to the world of food safety and quality.
Phoebe chose to join the Kellerman Consulting team because her core values align exactly with the values of our firm. She shares a passion for honesty, accountability and relentlessness. She strives to be transparent and supportive in all her interactions.
During Phoebe’s free time, she enjoys traveling to new places, painting, cooking, gardening and spending time with her family. She also happens to be fluent in French!
Moriah Seibert
Food Safety & Quality Consultant
Moriah holds a Bachelor of Science degree in Biological Sciences from Troy University and has earned numerous professional certifications, including:
- FSPCA Preventive Controls in Human Food
- Advanced HACCP
- Food Defense Plan Development and Implementation
- ISO 13485:2016 Internal Auditor – Medical Devices Quality
- American Society for Quality – Certified Quality Manager of Organizational Excellence
- American Society for Quality – Certified Quality Auditor
Her career journey over two decades has equipped her with extensive experience in quality management across diverse industries such as Medical Devices, Dairy, Juice, Meat, Seafood, Prepared Foods, Refrigerated Foods, Thermal Processing, Fruit Preparations, Beverages, Dietary Supplements, and contract manufacturing.
Moriah has successfully navigated through various certification programs, including BRCGS, NSF GMP & Certified for Sport, ISO 17025:2018, ISO 13485, ISO, Organic, Kosher, Halal, Marine Stewardship Council, Non-GMO Project Verified, Gluten-Free, and Vegan.
Moriah’s focus remains steadfast on improving the safety, quality, and integrity of food products and medical devices, ensuring consumers have access to safe and trustworthy options. She is dedicated to helping clients achieve their certification goals.
Andrew Bender
Food Safety & Quality Consultant
Zoe Kellerman
Food Safety & Quality Associate
As a Food Safety and Quality Associate, Zoe’s primary role at Kellerman Consulting is assisting the Food Safety & Quality Consultants with the creation of food safety and quality programs and providing additional support on client projects. Zoe helps our food safety & quality consulting team deliver client documents to meet agreed upon timelines.
Graduating from Rollins College with a B.A. in Environmental Studies, her interest in the complexities of the food system blossomed. Zoe has a particular interest in the environmental factors influencing our supply chain and the diverse regulatory and certification requirements shaping manufacturing, processing and distribution.
A foodie at heart, Zoe enjoys baking, cooking, and trying new foods. She also enjoys yoga and running in her free time.
Learn From Our Clients’ Experiences
SenSource Global Sourcing Gains ISO 9001:2015 Certification
Strong Spas Passes Their Costco Non-Foods GMP Certification Audit
WPackaging Receives an Excellent Score on their Costco GMP Supplier Audit
Lomo Cold Storage Receives 99.37% on Their GDP Audit
Folding-Carton Company, Everett Graphics, Obtains a Nearly Perfect Score on Their SQF Audit
Clarendon Flavors’ New SQF Practitioner is Trained in Three Months for SQF Success
Omakase Restaurant Group Receives Support for HACCP Plans & FSMA Program
Caprock Pecans Obtains 99% on their PrimusGFS Audit After Working with Kellerman Consulting
Patty Wagon Express Complies with FSMA to Grow Their Wholesale Business
Beach Cooperative Grain Achieves Excellence on Their SQF Audit
FSQA Manager is Trained in Four Months to Pass Their First BRCGS Audit
Apex Outdoor LLC Receives Approvals From USDA Regional Manager for Their HACCP Plans
Roka Akor gets ROP HACCP Plan Approved
Outer Aisle Gourmet Achieves SQF Certification for Three Sites
Premier Printing Corp Receives an Excellent SQF Audit Score on Their First Try
Joe Granato Produce has Their BRCGS Program Converted to an SQF Program to Keep Key Business
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