Project Management Medical Device

CAPABILITY STATEMENT

Black Star Universal Services LLC

**** ******** ****, *************, ** 30044

Website: Blackstaruniversa.com

Phone: 224-***-****

Email: *****.******@*****************.***

CAGE Code: 02V14

NAICS Codes: 541611

COMPANY OVERVIEW

Black Star Universal Services LLC is a small engineering firm specializing in concept-to-product solutions, offering comprehensive project management and engineering services. With expertise in medical device manufacturing, process development, validation, and automation, we help clients optimize production efficiency, ensure compliance, and achieve operational excellence. Our team brings over a decade of experience in leading high-impact engineering and project management initiatives.

CORE COMPETENCIES

• Project Management & Engineering Solutions

o Full lifecycle project management from planning to execution o Equipment qualification (IQ/OQ/PQ) and process validation o Lean Six Sigma and continuous process improvement

• Medical Device Manufacturing & Validation

o Process development for joining technologies, dispensing, cannula tipping, and pad printing o Quality Management Systems (QMS) and regulatory compliance (ISO 13485, 21 CFR Part 820) o Technology development, material testing, and specification preparation

• Automation & Manufacturing Support

o Semi-automated and automated equipment integration o Troubleshooting production floor challenges and enhancing efficiency o Cross-functional team collaboration with quality engineering and supply chain

• Facility & Equipment Expansion

o Leading new product development and pilot line commissioning o Site validation programs and manufacturing process transfers o Cleanroom, facilities, and equipment validation

DIFFERENTIATORS

• Extensive Industry Experience: Over 10 years of global experience in medical device manufacturing and process validation.

• Cross-Functional Leadership: Strong collaboration with quality, regulatory, and engineering teams to deliver projects efficiently.

• Regulatory Expertise: Proven track record of ensuring FDA, EU MDR, and ISO compliance.

• Concept-to-Product Expertise: Seamless transition from design to full-scale manufacturing.

• Customized Solutions: Tailored strategies to meet unique project needs and compliance requirements. PAST PERFORMANCE

• ICU Medical (C2C) – Led test engineering team and facilitated test strategy development to enhance testing methodologies.

• Alcon (C2C) – Directed a $40M facilities expansion for a new contact lens production line and R&D pilot line commissioning.

• Irrimax (C2C) – Spearheaded the qualification of a Type 2 Class medical device for the EU market.

• Flexan (C2C) – Managed the plant transfer and commissioning of the Neurocritical Care & Brain Injury Lab.

• Various Clients – Supported validation and transfer of documents, raw materials, and suppliers in corporate spin-offs.

CERTIFICATIONS & PARTNERSHIPS

• PMP Certified

• Lean Six Sigma

• ISO 13485 Compliance Expertise

• FDA and EU MDR Regulatory Knowledge

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