ISO 13485 Implementation & Certification
ISO 13485 certification is a globally recognized standard for quality management systems in the medical device industry, demonstrating a commitment to maintaining high standards for safety, quality, and consistency.
ISO 14971 Risk Management
ISO 14971 is a Internationally adopted standard for Risk Management in a Medical Device Industry which outlines the requirements for Medical Device companies to identify, assess and control potential hazards and risks throughout the product life cycle.
Medical Device Design Controls
Design Controls is structured requirement to carry out the Design and Development of Medical Devices. Design Controls includes Design & Development Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, Design Changes, Design History File.
Internal & External Audit
Audits in Medical Device Industry are systematic evaluations to ensure compliance with regulations, standards, and internal procedures, verifying product safety, performance, and quality.
US FDA 510(k) Submission
US FDA 510(k) submission is a premarket notification, required by manufacturers of medical devices to demonstrate that their device is substantially equivalent to a legally marketed device.
EU MDR 2017/745 CE Certification
CE Certification signifies compliance with EUs Medical Device Regulation 2017/745. CE marking is legally required for a Medical Device Company to place medical devices on the EU market.
IEC 62304 Software Development Life Cycle
IEC 62304 is an international standard that specifies life cycle requirements for the development of medical software and software within medical devices encompassing various stages from Software planning to Software maintenance.
Change Management
Change management in the medical device industry refers to the systematic process of managing modifications to products, processes, and systems to ensure they meet regulatory requirements, maintain safety, and improve efficiency.
Process Validation
Process Validation is to ensure a stable Medical Device Manufacturing Process which consistently produces a result or product meeting its predetermined specifications. Process Validation has three phases: Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ).
Test Method Validation
Test Method Validation in Medical Device Industry is to ensure that testing methods used are appropriate and the data generated from testing is reliable & repeatable.
Supplier Qualification & PPAP
Supplier Qualification in the Medical Device Industry is a process by which external suppliers are assessed to ensure their supply of services or products meets the customer requirements. Production Part Approval Process (PPAP) is an industry practice which ensures a supplier's ability to produce parts consistently and reliably to meet customer specifications.
CDSCO Certifications & Licenses
CDSCO (Central Drugs Standard Control Organization) licenses and certifications are mandatory for Medical Device Companies in India that manufacture, import, sell or distribute medical devices. These licenses and certifications ensure the safety, quality, and efficacy of these products before they reach the market