Bob Duffy provides solid World Class Product Development services in a wide range of disciplines and products. BDA professionals have years of experience successfully bringing products to market, and their product experience ranges from medical devices to consumer products.
Their activities include the following:
- Prepare 510(k)s
- Preparation and assessment of Technical Files and Design Dossiers
- Review of product literature/packaging/labeling
- Act as an On-Demand Compliance Engineer for your product safety needs supporting IEC 60601 series standards (Medical Electrical Equipment Standards)
- Set-up and maintain your company’s standards and regulations library,and Quality System
Our medical device regulatory experts can also provide expertise in the areas of Sterilization, Biocompatibility, Clinical Study support, and Software Validation.
CIRS works together with ESC to promote comprehensive regulatory services for medical device industries in America and China.
For more than a half century since its establishment, KTR (Korea Testing & Research Institute) has served as a leading internationally accredited testing·certification institute in Korea by diligently performing its functions as an on-site assistant for enterprises.
CIRS works together with KTR to promote comprehensive regulatory services for both clients.
KOTRA will help small and medium enterprises to transform into important export hubs, and help companies actively utilize various free trade agreements (FTAs) with countries such as China, Vietnam and New Zealand. In addition, they will do our best to provide opportunities for more companies to participate in one-on-one business meetings on the back of summit diplomacy talks to maximize results.
CIRS works together with KOTRA to promote comprehensive regulatory services for medical device industries in Korea and China.
Medical Regulations Gate (MRG) is a organization which can serve the precise solutions in complying with the Saudi medical regulatory requirements. And guarantee the comfort & confidence in pointing us as Authorized Representative in the Kingdome of Saudi Arabia and the Arabian Gulf region.
Nordic Business House specializes in connecting Nordic companies with the Chinese market. Their activities include the following:
Provide support in the start-up and development of sales phases of entering the market;
Act as a fully integrated part of our clients’ global sales organization;
Use our expertise to finance export efforts through public funds and EU grants;
Provide advisory services for clients in need of strategic support.
DR International is a regulatory consulting firm for companies that market or produce medicinal products for human and veterinary use, cosmetics, medical devices, biocides and food supplements. Their task is to guide companies through the current legislation and successfully meet the demands of our clients.