ISO 13485 2016 specifies quality management system requirements that organizations must demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. These organizations may be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation or maintenance of medical devices, design, development or provision of related activities (eg, technical support).ISO 13485:2016 is also available to vendors or external parties providing products to these organizations, including services related to quality management systems. Organizations do not need to actively manufacture medical devices to achieve ISO 13485 certification. Compliance with this ISO standard is considered a step toward meeting the built-in standards of the Global Harmonization Working Group (GHTF) guidelines. The inclusion of the certification standard will help medical device manufacturers establish a pragmatic approach to implementing the Medical Device Directive, demonstrate an organization's commitment to safe manufacturing practices, and demonstrate the quality of equipment produced in this way.
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It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services. In addition, the standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform. ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market
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Miss Manisha Katariya , the Team Leader of the Company, Post-graduated with a Master of Business Adminstration degree from AKTU (LUCKNOW). Miss, Manisha Katariya has nearly 7 Years of experience in the Sales & Finance sector. She heads the marketing and commercial relationship management departments of the Company.Their main duties include hiring and training employees, creating and implementing business strategies and delegating tasks to team members.
Mrs Priyanka Singh Chauhan Senior Associate of the company, Post graduated in Banking & Finance Management from NMIMS University , Surat Gujarat , Mrs. Chauhan has nearly 6 years experience in the finance and banking operations sector .
Miss Manali Sumrani Senior Associate of the company, Post graduated in Master of Business Adminstration in DRBAU University, Agra. Miss Manali Sumrani has nearly 5 years experience in the finance sector .
Miss. Twinkle Agarwal , the Consultant of the Company. She help their clients achieve their business goals by providing expert advice in their field of proficiency. She work with their clients and advise them on matters such as accounting and Legal Services.
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Mr Mohan Sharma Advisor of the company, Graduated with Bachelor of Computer Application Degree from DBRAU Agra.He meet with clients to gain a sense of their mindset and ultimate goals. He draw from their experience, expertise, and perspective to help clients shape their goals and craft purposeful next steps.
Miss Kareena Varlani Associate of the company, Graduated with Bachelor of Commerce Degree from Dayal bagh University Agra.She work in collaboration with others to complete daily tasks and offer support to their team.
