Our first Webinar with APRA: Watch it here!

Our first Webinar with APRA: Watch it here!

Join us for a Live Webinar, hosted by Jason!

Organised with the Asia Regulatory Professional Association, we will be hosting a webinar on how companies can adopt standards with ease and automate QMS processes on the cloud. In this webinar session, we will be sharing on the common difficulties companies face and how we intend to tackle them directly!

Training Workshop: Digitalisation of your QMS (Supported by WSG)

Training Workshop: Digitalisation of your QMS (Supported by WSG)

Singapore Manufacturing Federation (SMF), in collaboration with Stendard, is bringing you a 2-day workshop. This workshop focuses on providing an overview of the ISO 13485:2016 and how these requirements can be continuously met using an Enterprise Quality Management Software System (EQMS). We will also be sharing how effective implementation of the standard can help companies fulfill medical device regulatory requirements globally.

What is a Regulatory Strategy? How can I create one?

What is a Regulatory Strategy? How can I create one?

Due to differences in laws and regulations across international markets, the same product claim or intended use can require varying actions to be taken with regards to product classification and registration. This creates multiple roadblocks for medical devices to be registered and brought to market.

All companies want to get their product to market as quickly and as efficiently as possible. This can be achieved if such differences are considered, and a regulatory strategy is in place. Here are 3 points to consider when crafting your strategy.

What must I do to kickstart my design process?

What must I do to kickstart my design process?

With Design and Development (D&D) being a core process of your business, having a clear D&D work structure is important. The structure your Quality Management System provides helps with maintaining systematic business practices for maximum efficiency. Here are 5 items to be set in place at the start of your D&D work structure.