Medzus | About Us
Open

Medzus Laboratories


A Medical Device, IVD and Drug –Device Combination Product expert located in the heart of Vadodara, Gujarat, India.


Medzus Healthcare


The root company was established in 2012 and bought up with providing various technical services to healthcare & pharmaceutical industries.


Medzus Medical


Onward of early 2013 the company has came up with the aim of support to ongoing worldwide patient safety initiatives dedicated to reducing tubing misconnections by manufacturing & supplying of various disposable medical devices in compliance with ISO 80369.


Through the understanding of a Medical & Pharmaceutical combination product need; Medzus Laboratories has been established in late 2013.

In era of medical devices and drug-device combination products; Medzus Laboratories services start with product design & development to batch release; Medzus specialize in Product design, Assembly, Packaging, Sterilization and Laboratory Testing’s.

Research and development is the main strength of the company. A modern laboratory equipped with pilot plant facilities develops new products very certainly.

Company has now been grown up with vast experienced Scientist, Engineers, Doctors and various Technology Experts. Medzus is now widely recognized for its superior service, competitive prices, and innovative value-added solutions,

Firm is dedicated in providing services with the following core pillars -

Combination Products - One pillar Medzus project portfolio is the support of drug-device combination products. Medzus has key competencies in the project management, regulatory affairs and quality consulting for autoinjectors; pens, and needle-safety devices.

Knowledge and experience from Medzus regarding combination products are globally unique and make Medzus a valued partner of numerous pharma-, biotech-, biosimilar- and medical technology companies, ranging from startups to global industry leaders. It does not matter whether the combination products are prefilled syringes with or without a needle safety system, auto-injectors, pen-injectors, inhalers, stents or drug- eluting patches.

With some customers we are closely involved from the definition of the user requirements until the postmarket surveillance, whilst with others we help develop the regulatory strategy or the design control procedure. Our consultants have hundreds of years’ worth of hands-on experience. This allows us to offer a uniquely broad and in- depth range of services.

Our range of services encompasses regulatory affairs, quality management (21 CFR Part 4), design control, risk management, usability engineering/human factors, clinical evaluations, labelling, production, process validation, supply chain, postmarket surveillance, auditing and training. In addition, we develop our own innovative approach to the modular construction of Design History Files (DHF), which enables a quantum leap in the maintenance of DHFs.

Medical Devices - Medzus also has extensive knowledge in class I, class II, and class III medical devices, as well as IVD medical devices, and supports customers during every phase of the product lifecycle.

Technical documentation like Risk Management, CAPA, and Design Control are easily managed by appropriate software tools. Especially in the field of requirements regulatory documentation. Medzus medical can offer slim but effective tools to make sure your DHF documentation is always up to date.

Medzus healthcare staff will assist you on each critical process of Medical & pharmaceutical QA & Regulatory Submission. Also provide you better service through the experienced personalities by following ways.

The auditors at Medzus are assigned to your project from its initiation and full compliance is assured through in-life, in-process, protocol, data, documentation and report audits conducted on every study or project. Our standard operating procedures (SOPs), test methods and training documentation are all issued and maintained under strict document control by our quality assurance group. Our team and processes assure regulatory compliance with FDA, CE guidelines that include but are not limited to GLPs, cGMPs, ISO and ICH Q7 guidelines.

Throughout the progress of your study, all documents/data are archived to assure complete and accurate documentation in addition to the retention to regulatory requirements. All validation/qualification programs are coordinated through validation specialists on our team in conjunction with the operational divisions and the corporate computer validation committee.

While our focus and dedication for our quality assurance staff is internally driven, and the associates are available for consulting audits.

We do testing & gives solution for functional & performance testing of various range of surgical medical devices, IVD and Combination products as per FDA, CE, ASTM, and ISO guidelines. Our services help in test method development, method validation, process optimization & process validation. Also provide best solution for biocompatibility testing, chemical testing, and stability testing and clinical evaluation of medical devices. We specialize in calibration & testing services for all small bore connectors specified in ISO 80369-1 to 7 & 20. We are able to help for customized testing application to makes your idea workable.

Our medical device manufacturing services gives you complete solution for your product to be launched in market. We involved in the following segments of sourcing &implementation – Medzus Medical has complete range of disposable device manufacturing capabilities and the ability to create custom equipment allows us to produce complex, intricate devices to your specifications.

We use & apply various different techniques, machines & instruments for successful launching of your requirement with considering international harmonized standards. Also helps you to makes your idea workable for customized application.

Service Response

Modern order processing facilitates a rapid response to customer requests. Medzus marketing personnel are prompt in responding to customer inquiry & also after sale services and collecting their feedback for continuous improvements.

Market Potential

Our work culture & service leads to catching up the global customer. We have been encouraged with our lots of satisfied customers from all over the world for approaching us to give services at all time.

Now a day’s newly designed Medzus devices fast catching up globally & that’s proves our market potential.

Vision

Enhance the quality of life by maximizing our contribution to healthcare environment.

Mission

Our mission is to research, develop, manufacture and market medical device and combination products to meet our customers' expectations in terms of quality, delivery and cost efficiency.

Future Plans


By recognizing the importance of R&D in Healthcare, Pharmaceutical and Medical device industries, Medzus has plan to be a leader in service provider of above zone. We aim to involve in many of projects with our vision of "Enhancing the quality of life by maximizing our contribution to healthcare process".