In the course of the manufacturing process, medical device makers strive to be more efficient and fast, but they also want to be more cost effective. Medical device manufacturing includes all aspects of the fabrication of a medical device, from designing a manufacturing process to sterilization and packaging of a device for shipment. 

Aren’t you happy with current manufacturer? Are there any other manufacturers which can compete with the current manufacturer? 

The key elements to evalute each manufacturing process are:

1. quality standarts of the facility
2. production capacity
3. leadtime
4. cost

Still, while speed and cost-savings are vital to successful manufacturing, quality control is of the utmost importance — particularly as medical device market demands shift toward a more value-driven landscape. Packaging validation, proving to the FDA that a product is sterile when it ships, is the final step.

The standards that must be met to successfully sell medical devices are:

• ISO 13485:2016 – The International Organisation for Standardisation’s requirements for medical device quality management systems. This was reviewed in 2020 and has been adopted by many countries globally
• 21 CFR 820 – Overseen by the United States Food & Drug Administration, this Code of Federal Regulations sets out quality system regulations and good manufacturing practices for medical devices made or sold in the United States. It roughly aligns with ISO 13485 without being equivalent.
• The European Union’s Medical Device Regulation (MDR) – formally known as Regulation (EU) 2017/745 – which sets out rules for medical devices sold in the EU. Full compliance was due to be in force by May 2020 but was delayed until May 2021 to avoid impacting the rapid rollout of a Covid-19 response, in particular the many new respirators needed worldwide.
• The Unique Device Identification System (UDI) final rule – US legislation requiring medical devices to be uniquely trackable in line with new UDI rules set out in the EU MDR regulations above. As of June 2020 enforcement of UDI legislation has been delayed for some classes of medical device until 2022 due to Covid-19 disruptions.

Many medical device manufacturers excel in the ideation, concept, and prototyping phases of product development and outsource the production of components or entire devices to contract manufacturers. This is as true of established original equipment manufacturers (OEMs) as it is for mid-sized companies and startups.

There are contract manufacturers that specialize in small, precise operations where they’re able to provide you with components that meet your exact specifications, and others that have extensive, state-of-the-art cleanrooms, complete with the right equipment for large-scale production.

With our experience we will support you with best options to start your OEM production. We have a huge experience in manufacturing of OEM products. We have a team of qualified professionals who are well versed with latest technology and trends of the industry. With their guidance we make sure that your requirements are fulfilled in the best possible way.