As a medical device manufacturer, Indilab performs all design and manufacturing processes in accordance to the requirements defined in 21 CFR 820 (U.S. Food and Drug Administration, Good Laboratory Practices and Quality System regulations) and international quality system standard ISO 13485:2016.
Our dedication to achieving customer satisfaction is backed by our
best practices and quality product
Our Franklin Park, IL manufacturing facility is registered with the Food and Drug Administration, Facility #1450962.
Our Quality + Compliance
- ISO 13485:2016 Certified
- FDA Quality System Requirements
- Quality System Assessment
- Process and Product Controls
- Vendor Management
- Statistical Process Control (SPC)
- Design of Experiments (DOE)
PROTOCOLS AND PROCEDURES
- All manufacturing conducted by Indilab is tested according to established written standard operating procedures, specific protocols or study plans, as appropriate.
- Indilab, Inc., utilizes a structured development process where the idea for a product, service, process, or business is progressively developed, documented, reviewed, and ultimately deployed for business growth. This model ensures the development of well-defined requirements based on customer needs and regulations (design input), appropriate design review stages, and verification that the design output meets specified requirements. At the end of the process, a final validation is performed against design input.
- Risk analysis is performed throughout development according to ISO14971.
- Processes are controlled and monitored to maintain conformance with specified design requirements.
- Raw materials, in-process materials and final product are assigned control numbers for traceability and documented throughout the production processes.
- Strict manufacturing quality guidelines are followed to assure valid data.
- Each step of manufacturing operations is carefully controlled to assure accurate, consistent, and reliable products.
- Members of Indilabs staff are selected and trained for specific job functions.
- Records are maintained through documentation of all design, production and control monitoring activities.
AUDITING AND REVIEW
- Indilab routinely reviews our quality system for continuous improvement. Process-based audits, facility audits, and testing-based audits from an independent quality assurance unit are utilized to identify and correct deficiencies before they adversely affect the company’s products and reputation for quality.
- Internal audit programs evaluate the interaction of people with systems, processes, procedures, and operations to assure that design requirements and customer expectations are safely and reliably met.
Detect significant deviations from design specifications, and adjust operations as needed to achieve desired assurance of uniformity in compliance with standards.
Secure and utilize information in order to facilitate the anticipation and prevention of problems.
- Utilize calibrated equipment that is traceable to national standards to monitor all stages of manufacturing.
- Independent and regulatory auditors routinely visit Indilab’s facility to verify compliance with the quality system standards.