ISO 13485: 2016

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for : Implementation of a Quality Management System with several enhancements. Risk Management approach to product development and product realization. Validation of processes. Compliance with statutory and regulatory requirements. Effective product traceability and recall systems. Access Filings offers ISO 13485: 2016 for Rs.22,999/-

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ISO 13485: 2016
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  • From Rs.22999/- all inclusive fees EMI: Rs.1917/- for 12 months*

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ISO 13485: 2016 Registration with Three Years Validity..

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ISO 13485: 2016 Registration with Three Years Validity..

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ISO 13485: 2016 Registration with three years validity & Trade Mark Registration..

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TWO COPIES OF SALES BILL & TWO COPIES OF PURCHASE BILL

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical  Devices
ISO 13485:2016 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices throughout the world. Certification to ISO 13485 requires its quality system to pass a 3rd party MDSAP audit.
ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives.
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements.
Reduced operating costs - through continual improvement of processes and resulting operational efficiencies.
Improved stakeholder relationships - including staff, customers and suppliers.
Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers.
Improved risk management - through greater consistency and traceability of products and use of risk management techniques.
Proven business credentials - through independent verification against recognized standards.
Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.
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Proprietorship is for the Proprietor to do Business. Access Filings offer Proprietorship Registration from Rs.2799/-.

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REGISTRATION

For Certain Businesses, Registration Under GST is Mandatory. Access Filings offers Online GST Registration from Rs.2,899/-.

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TRADEMARK REGISTRATION

Trade Mark Registration helps establish ownership and protect brand of an entity. Access Filings offer Trade Mark Registration from Rs.6,501/-.

ISO REGISTRATION

ISO REGISTRATION

ISO 9001:2015 is the International Standard for Quality Management Systems (QMS). It provides your company with a set of principles that ensure a common sense approach to the management of your business activities to consistently achieve customer satisfaction. Access Filings offers ISO 9001: 2015 for Rs.11,800/-.

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COMPLIANCE

The name of a company or LLP can be changed with Board of Directors and Shareholders approval. Access Filings offers an easy process for changing company or LLP name from Rs.15899/-.

TAX FILING

TAX FILING

Prepare your accounts and file your business income tax return with Tax Advisor assistance through Access Filings at just Rs.4999/-.

TRADEMARK REGISTRATION

TRADEMARK REGISTRATION

A trademark is a recognizable sign, design, or expression which identifies products or services of a particular source from those of others,although trademarks used to identify services are usually called service marks. The trademark owner can be an individual, business organization, or any legal entity. A trademark may be located on a package, a label, a voucher, or on the product itself. For the sake of corporate identity, trademarks are often displayed on company buildings.

ISO REGISTRATION

ISO REGISTRATION

The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations. Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. It is headquartered in Geneva, Switzerland and works in 162 countries. It was one of the first organizations granted general consultative status with the United Nations Economic and Social Council.

TAX FILING

TAX FILING

Income Tax Return is the form in when assessee files information about his Income and tax thereon to Income Tax Department. Various forms are ITR 1, ITR 2, ITR 3, ITR 4, ITR 5, ITR 6 and ITR 7. When you file a belated return, you are not allowed to carry forward certain losses.The Income Tax Act, 1961, and the Income Tax Rules, 1962, obligates citizens to file returns with the Income Tax Department at the end of every financial year. These returns should be filed before the specified due date. Every Income Tax Return Form is applicable to a certain section of the Assessees.

COMPLIANCE

COMPLIANCE

The name adopted by a private limited company during incorporation can be changed later. To change the name of a private limited company, the consent of the shareholders through a special resolution and MCA approval are required. The change of name of a private limited company has no impact on its legal entity or its existence as a corporate entity. The change of name of a company will not create a new company or new entity.

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