I am looking at expanding overseas. What markets do you cover?
Our client base is located all over the world!
Besides applying the internationally-recognised ISO standards, we have specifically helped them expand to Europe, USA, Canada, South Korea, Australia, ASEAN regions. Our ISO consultants are able to provide guidance to fulfill what is required for successful manufacture, importation, and distribution of your products.
Do you provide services for medical device product registration?
Yes, we have plenty of experience in supporting medical device product registrations in various markets throughout the world. Our consultants focused on regulatory compliance would be able to advise on the relevant submission process and documentation requirements.
Files
What should I do if I cannot open the file I receive?
All files are in either PDF or ZIP format. Please make sure that you have proper software installed to open the file. If you still have issue with opening the files, please Contact Us.
Are all the files printable and multi-user?
Yes, all files are full-access, printable and multi-user.
When can I download my purchased documents?
After payment is completed, we will send the documents to the email address you used for payment.
Management
How should I define or scope my Quality Management System (QMS)?
It is recommended for companies to include any activity covered to bring the product to the market. This covers Design & Development, Manufacturing, Distribution, and if applicable, servicing and sterilisation. As a Product Owner, one would include Manufacturing and Distribution activities, even if they have not started, or are to be outsourced. Listing only Design and Development would apply to companies that specialise in and only perform D&D.
What consultancy services do you provide?
Our team of in-house consultants have experience in matters relating to Regulatory and Quality subjects, and are able to provide advisory services in these areas. For more information, please refer to our Consultancy Services page.
