Biolytic Lab Performance, Inc.

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You are here: Biolytic Lab Performance, Inc | Quality and Regulatory
Sunday, 10 Aug 2025

OUR QUALITY POLICY

At Biolytic, we are committed to delivering high-quality products and services that meet the needs of scientific and research communities around the world. We uphold quality through robust design, consistent manufacturing practices, and a culture of continuous improvement. Our quality system aligns with ISO 9001:2015 and is focused on ensuring safety, traceability, and reliability in every instrument and component we produce.

We foster a collaborative environment across teams to ensure that quality is integrated at every stage, from development to delivery. We listen to our customers, respond to regulatory changes, and actively review our systems to support evolving research needs while maintaining scientific and operational integrity.

"Quality isn’t just a process. It’s how we lead, how we build, and how we earn trust. We hold ourselves to high standards not because it’s expected but because it’s who we are; consistent, accountable, and focused on delivering real value where it matters most.”

— James Demmitt, CEO, Biolytic Lab Performance, Inc.

OUR VISION

Our vision is to consistently exceed expectations in safety, quality, delivery, innovation, sustainability, cost, and value, while fostering a culture built on clarity, collaboration, and continual improvement.

QUALITY AT EVERY STEP

Premium Materials

We source only high-grade materials and components to ensure long-term durability, precision, and consistent performance across all our products.

For selected consumables, we provide documentation for:
- Certificate of Analysis (CoA)
- Certificate of Quality (CoQ)
- MSDS

Expert Assembly

Every instrument is meticulously assembled by trained technicians following standardized procedures that ensure consistency and reliability.

Thorough QC Inspections

After assembly, each instrument undergoes rigorous quality control inspections to verify that all systems meet our strict performance and safety standards.

We provide documentation for:
- Certificate of Quality
- Declaration of Conformity (CE) at an additional cost
- Training Certificates

Comprehensive Qualification Services

We offer a full range of qualification services, including Installation Qualification (IQ), Operational Qualification (OQ), and Preventative Maintenance (PM) to support regulatory compliance and lab readiness from day one.

Learn more about our qualifications services here:
IQ OQ PM Instrument Hardware Qualifications

COMPLIANCE

Biolytic aligns with applicable regulatory standards and industry best practices to support evolving research needs and ensure dependable performance. While our instruments are labeled for Research Use Only (RUO) and not intended for diagnostic or therapeutic use, we are committed to maintaining quality, traceability, and transparency across all operations.

FREQUENTLY ASKED QUESTIONS

Are you ISO 9001 Certified?
We are not ISO 9001 certified however we follow standard best practices and are working towards ISO 9001 certification.

Are you ISO 13485 Certified?
We are not a medical device company and therefore not ISO 13485 certified.

Is your software 21 CFR compliant?
Our software is not 21 CFR Part 11 certified. However, it includes controls and features that can support customer compliance when configured and validated appropriately. It remains the customer's responsibility to validate their full system for 21 CFR compliance.

Are you GMP Certified?
We are not GMP certified. We offer IQ and OQ services to help our customers work towards GMP or other certifications and validations a customer might need in their production facility. Other certifications may be dictated by local standards and government regulations. It is the customers responsibility to have their entire process validated and put into compliance to be considered GMP certified.

Are your Instruments and Accessories CE Certified?
Yes all of applicable Dr. Oligo line of instruments and accessories are CE certified. CE Certificates available for an added cost.

Are your Instruments and Accessories UL Certified?
Yes our instruments are UL 60950-1 certified and must re-certified upon install.

Are your Instruments and Accessories TUV Certified with NFPA 70/79 Field Label?
Yes, we are able to provide the TUV Field Inspection and apply an NFPA 70/79 Field Label for each instrument or accessory for an added cost.

Does Biolytic comply with the U.S. Framework for Nucleic Acid Synthesis Screening?
Biolytic Lab Performance, Inc. attests to full compliance with the U.S. Framework for Nucleic Acid Synthesis Screening. We are committed to upholding the highest standards of ethical conduct and regulatory adherence in all our operations. If this information should change, this attestation will be updated within 72 hours. We regularly review our practices in light of federal guidance and executive orders, including the May 2025 Executive Order on Biological Research. For more information, please contact us at info@biolytic.com.

What is the intended use of Biolytic’s Dr. Oligo synthesizers?
While our customers’ use of our instruments for scientific applications is wide-ranging and impactful, all Biolytic instruments, including Dr. Oligo synthesizers, are labeled for Research Use Only (RUO). They are not intended for diagnostic, therapeutic, or clinical use. Customers pursuing regulated applications must independently validate their workflows, instruments, and processes to meet the standards of their intended use. Biolytic does not validate its instruments for clinical, therapeutic, or in vitro diagnostic (IVD) use.

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