Need help with ISO 13485 ?

EUISO 13485 certification is a basic requirement for CE certification for your medical device product.

Many Medical Device Companies try to handle ISO 13485 compliance in house – often with disastrous results.

Wading through the regulatory thicket on your own is a daunting task for even the most talented staff.

Let’s face it – you need help with ISO 13485 compliance.

Go with a Company that has the experience and expertise you need.

That’s where Yakar Engineering comes in.

With offices in Israel and the US, Yakar Engineering provide high level Quality, Regulatory and Clinical Affairs services to startup companies & entrepreneurs, across a wide range of medical disciplines, in the most efficient and cost-effective manner.

Yakar Engineering boasts a multi-disciplinary team of highly experienced engineers, pharmacists, and regulatory experts. The team is driven by professional skill, industry experience and an exceptionally detailed knowledge of the medical device and pharmaceutical startup sectors.

Our regulatory experience and expertise covers the US, EU, China, MDSAP countries (Japan, Brazil, Australia, Canada) and Russia.

With over 17 years of experience of Quality & Regulatory Affairs experience, we can help with your ISO 13485 certification today. 

With a wide network of professionals around the globe, there’s no job we can’t handle, while being cognizant of our client’s requirements and financial situation.

Don’t pay top dollar to a second tier consulting firm. Give us a call or shoot us an email today.

Your satisfaction is our number 1 priority.