A Belgian company specialized in quality and regulatory affairs services is offering services agreement to companies bringing medical devices to the market

Annotation

The Belgian company provides the following services to medical device providers: - Quality Management System (QMS) - Regulatory affairs - Audit assistance - Interim service as Quality Assurance or Regulatory Affairs manager The company is looking for partners providing new medical devices providers to propose services agreement for regulatory affairs assistance and quality management.

Offer description

The Belgian company provides his expertise in quality and regulatory affairs to companies bringing medical devices to the market, supporting them on specific projects or on the long-term supporting them in their quality management. The company has a long experience in regulatory affairs in the medical devices sector. It provides the following services to medical device providers: - Regulatory affairs assistance for new product introduction: CE marking and Food and Drug Administration for the USA - Quality Management assistance: setup, implementation and maintenance of Quality Management System (QMS) according to ISO13485 - Audit assistance (internal, external, notified bodies) - Interim service as Quality Assurance or Regulatory Affairs manager The company is looking for new medical devices providers to propose services agreement for regulatory affairs assistance and quality management. The company has no preference concerning the targeted countries.

Innovations and advantages

Experience with all processes concerned with medical device commercialization: R&D / Purchase / Manufacturing / Assembling / Packaging / Expertise in sterilization aspects (EO and steam)

Market application codes

02007025 Consulting services
05007007 Other medical/health related (not elsewhere classified)

Profile date

16.03.2019