ISO 13485:2016

ISO 13485:2016 defines the requirements for a quality management system in situations where an organisation must demonstrate its ability to consistently provide medical devices and related services that meet customer and applicable regulatory requirements. Such organisations may be involved in one or more stages of the life-cycle of a medical device, such as design and development, production, storage and distribution, installation, or servicing, as well as design and development or provision of associated activities (e.g. technical support).
ISO 13485:2016 Requirement
Except where explicitly stated, ISO 13485:2016 requirements apply to organisations of any size and type. Where requirements are specified as applying to medical devices, the requirements also apply to the organization's associated services.

Frequently Asked Questions

What is a Private Limited Company?
Private Limited Company is the most sought form of Company Registration in India. It is the most preferred form of business and regulated by Ministry of Corporate Affairs (MCA) under Companies Act, 2013. A Private Limited Company is a type of business structure registered with MCA to give a separate legal existence to the business different from its directors and shareholders. This means that a company continues to exist even after the death of any member/director in the company.
A minimum of two persons are required to form a Private Limited Company. It is not even important that members should be different from directors. In a company, two persons can act as Members and Directors both at the same time. Members and Shareholders are one in the same. That means an individual may become shareholder and director at the same time.
There is no minimum capital requirement to form a Private Limited Company Registration. Start-ups may choose on their own how much paid-up capital they want to keep during the Company Registration. However, generally one lac capital is kept as per most companies registered.
Name reservation is quite simple and easy to obtain. Our professionals will guide and help you in choosing the best suitable name of your company according to name guidelines of company incorporation and trademark laws.
Director Identification Number (DIN) is a unique number assigned by the MCA to Individuals allowing them to become Director in any Company or Designated Partner in an LLP (In LLP, it is called DPIN). Any natural person above the age of 18 years can become the director in the company after getting DIN. There are no specific regulations provided in terms of citizenship or residency, also a foreign national can become a director.
Digital Signature Certificates (DSC) are the digital equivalent (electronic format) of physical or paper-based certificates. Likewise, a digital certificate can be presented electronically to prove one's identity, to access information or services on the Internet or to sign certain documents digitally. SPICE+ forms are filed for online company registration after affixing the DSC. The subscribers to MOA & AOA shall possess DSC for submitting e-forms for incorporation.
Memorandum of Association (MOA) is a legal document prepared during the registration process of a company to define its relationship with shareholders and contains the main objectives of the company. Articles of Association (AOA) are by-laws of the company and it regulates management of a company and creates certain rights and obligations between the members and the company.
Yes, Startups get benefits of getting themselves registered as a Start-up under DPIIT and avail many benefits launched by the Govt. Corporates recognize Private Limited Company very well and the foremost advantage is of credibility and good reputation of the established business in the eyes of Investors, Incubation Centres, Financial Institutions and Customers at large.
Post incorporation compliances are easy and manageable. Companies Act, 2013 provides a lot of exemptions to private Companies due to which compliances becomes easy and handy. At CCL, Professionals are there to manage each and every compliance of your company. Get in touch with us to know the post incorporation compliance especially commencement of business.
No, With Compliance Calendar LLP, no compliance is complicated. Our team is here to manage each and every thing when it is about managing company compliances.
We are the market experts in registration and compliance of Companies. We can help you with end-to-end services in Private Limited Registration anywhere in India. Company Registration is a legal process and therefore it is prudent to assign the work to a professionally managed firm like CCL.
Not to worry at all! A Professional from our experienced team will resolve all your queries. Our Company Registration Experts will give you the best advice without any consultancy fees.