Business Details
Trusted Medical Device Manufacturing Partner
Founded on principles of trust and collaboration, Coghlin Companies has established itself as a leader in designing and manufacturing complex capital equipment and medical devices. Our proprietary Scaled Product Launch (SPL) process accelerates time-to-market while reducing costs through a structured phase-gate approach. With vertically integrated capabilities including in-house printed circuit board assembly (PCBA) and certified Class 7 clean rooms, we maintain strict quality control across critical production stages. Our global supply chain expertise combines advanced software tools with long-standing supplier relationships to ensure component availability without compromising quality. Holding ISO 9001:2015, ISO 13485:2016, and ITAR certifications demonstrates our commitment to regulatory compliance.The company's 24/7 production capacity and infinite scalability model enable clients to meet unpredictable market demands. Client testimonials consistently highlight our customer-centric approach, technical expertise in laser/optical technologies, and ability to handle complex projects like FDA-compliant medical device commercialization. Our culture of continuous improvement and employee engagement directly translates to superior client outcomes. Strategic investments in automation, traceability systems, and workforce development maintain our competitive edge. This combination of technical capabilities, regulatory expertise, and client-focused values has made Coghlin Companies a trusted partner for industries ranging from medical and semiconductor to security and energy sectors.
Services
Medical Device Manufacturing
Capital Equipment Production
Supply Chain Optimization
DFM & Modularity
Compliance Certifications
Infinite Capacity Management
PCBA Services
Product Commercialization
Aftermarket Services
Clean Room Manufacturing
Highlights and features
- Proprietary Scaled Product Launch process for efficient market entry
- Vertically integrated in-house printed circuit board assembly capabilities
- Advanced global supply chain with transparent cost modeling
- ISO 9001 and 13485 certified manufacturing facilities
- 24/7 production availability with infinite capacity scalability
Associations and certifications
- ISO 9001:2015
- ISO 13485:2016
- UL Certification
- RoHS Compliant
- ITAR Registered
What people say
Pleasure to work with
True highlight of my career
Customer-obsessed
Commitment to our success
Reliable manufacturing partner
Services
Medical Device Manufacturing
Specialized production of FDA-compliant medical devices including diagnostics, surgical tools, and imaging equipment. Our Class 7 clean rooms and 21 CFR 820.30 compliance ensure regulatory adherence. Laser and optical technology expertise supports complex device fabrication with strict quality controls.
Capital Equipment Production
Design and manufacturing of complex capital equipment for robotics, semiconductors, and security industries. Vertical integration with in-house PCBA reduces lead times. Advanced testing capabilities include AOI, 3D X-Ray, and in-circuit validation to ensure precision performance.
Supply Chain Optimization
Global supply chain management with transparent cost modeling and component sourcing. Our network of trusted suppliers balances cost, lead time, and quality. Serialization and traceability systems ensure complete material accountability throughout production cycles.
Compliance Certifications
Full compliance with ISO 9001, ISO 13485, UL, and ITAR standards. Expertise in CE, CSA, and IEC requirements supports global market access. Documentation verification and validation processes ensure products meet all statutory and regulatory requirements.
Infinite Capacity Scalability
24/7 production capabilities with flexible capacity to meet unpredictable demand. Finished goods storage and distribution systems support rapid market response. Aftermarket services include refurbishment and ongoing technical support for sustained product lifecycles.
People
Meher Nerkizian
Co-Founder & COO
Co-founder driving operational excellence and client relationships. Focuses on maintaining the company's family culture while ensuring adaptability to client challenges through strategic leadership.
Rick Couto
VP of Manufacturing
Manufacturing leader transforming security technology production. Emphasizes team collaboration to achieve mission-critical objectives while maintaining quality standards in complex manufacturing environments.
Brian Quaglieri
Product Quality Engineering Manager
Quality assurance expert ensuring product excellence through rigorous engineering processes. Known for flexibility and commitment to finding solutions that meet client specifications and regulatory requirements.
Jaclyn Setina
External Manufacturing Manager
Supply chain strategist ensuring reliable production of critical components. Focuses on building strong partnerships that enhance product quality while maintaining efficient manufacturing timelines.
Gene Tracy
VP Engineering & Manufacturing
Engineering leader overseeing development of advanced manufacturing systems. Combines technical expertise with practical implementation to deliver reliable production solutions for complex technology requirements.
Questions
What industries do you serve?
We support robotics, semiconductors, security, medical, life sciences, food service, energy, and additive manufacturing sectors with specialized production capabilities.
Are you FDA-compliant?
Yes, we specialize in FDA-compliant medical device commercialization with certified clean rooms and documentation per 21 CFR 820.30 requirements.
How do you handle supply chain challenges?
Our global supply chain combines advanced software tools, transparent communication, and trusted supplier relationships to ensure component availability without compromising quality.
What manufacturing certifications do you hold?
We maintain ISO 9001:2015, ISO 13485:2016, UL Certification, RoHS compliance, and ITAR registration for regulatory adherence across multiple industries.
Can you handle large-scale production?
Our infinite capacity model with 24/7 production availability ensures scalable manufacturing to meet unpredictable market demands while maintaining quality standards.
What makes your process unique?
Our proprietary Scaled Product Launch (SPL) process combines phase-gate methodology with intense collaboration to accelerate time-to-market while reducing costs.
Reviews (3)
Danny Vee
Apr 26, 2021
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Came for an interview... didn't even get one. Sat with the supervisor in building 53 for less than a min and was told I was going straight into testing my skills in soldering which I already said I have no knowledge in soldering that specific circuit board to the recruiter and even to employer. I was handed my tools and told do the best I can. I wasn't set up for success at all. No procedure book in place no one said or showed me an example. No one sitting besides me to guide me. All I got was a piece of paper showing me the circuit board what goes where but not specific details. Bad experience
Paul Turner
Feb 20, 2021
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I went there with a positive attitude and was excited to work there at first. My training was cut short due lack of drivers. I never received the training to operate the electric fork lift to unload truck and had to hunt down help at times to help me load and unload extremely heavy loads which made the job almost impossible at times. I kept asking managers when I would receive my training and was always blown off. I was also hired for a shift that did not exist as well. The trucks were junk and when you reported a problem one would laugh and the other would say we are working on it. It really should
Zachary Thibodeau
Aug 27, 2019
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From what I've heard this place is a horrible place to work and everybody is doing drugs while working and there are now chairs to sit down while working all day doesn't sound like a place I would wanna work.
