Do you need help to get your healthcare solution to the market? If only it was as simple to get a diagnostic device, medical device or a drug to the market as it is to get a tennis racket to the market. But patients’ lives are at stake, which makes the need for thorough control and regulation inevitable.

There are a lot of regulations to meet and they are different from region to region. Getting such a health care product to the market not only requires standardization of processes, a good working Quality Management System (QMS) and a proper technical file with all the evidence of the product’s safety and efficacy. It also requires a good marketing and business plan, thorough project planning, and deep pockets.

B-liss has extensive experience in getting health care related products to the market and can therefore provide guidance how to meet the applicable regulations.

Some keywords:
Product development, Translational science, Valorization, Technology transfer, Marketing, Project planning, Budgeting, CE registration, FDA clearance, FDA pre market approval.

Do you want to standardize and improve the quality of your laboratory and production processes? Doesn’t it often feel that implementing and using a quality system just cost time and money, makes your operations too rigid, and does not benefit you at all?

On the contrary, B-liss has extensive experience and examples where a good working quality system actually saved a lot of money, and timely prevented a lot of harm to patients.

B-liss can provide guidance and support to get your processes and quality management to the next level in such a way that you can actually benefit from it.

Some keywords:
Quality management systems, QMS, GxP, GMP, GLP, GCP, 21CRF820, ISO-13485, ISO-15189, Standard Operating Procedures, SOP’s, Audits, Reviews, CAPA management, Deviation handling, Non-conformity handling, Training

Do you want to serve patients with high quality, safe and efficacious products and solutions?

Obviously, everybody wants to do so. However, how do you demonstrate your products indeed are safe, reliable and efficacious? How do you demonstrate your product is suitable for it’s purpose?

In order to do so, a lot of experiments are required and a lot of documented evidence is required.

B-liss has extensive experience in product development including risk management, quality by design, analytical, software and clinical validation, which are all powerful tools to generate such evidence of the product safety, reliability and efficacy and can therefore provide guidance how to establish this evidence.

Some keywords:
Product lifecycle, Design history file, Design control, Technical file, QA/RA, Risk management, Quality by design, Validation, Compliance, Protocols, Development plans, Assay development, Instructions for Use, Software development, Analytical validation, Software validation, Clinical validation, QA/RA, Complaint handling, Post-marketing surveillance, Adverse event reporting.

Do you want to understand more about GMP and other regulations and standards in healthcare? Do health care related regulations and standards seem to be one big jungle to you?

Are you a researcher, or research organization and are you developing, or about to develop, health care products or services intended for patients that need to meet European and/or other country’s regulations? Do you want to understand more about the applicable regulations you need to comply with, and how to meet them?

B-liss has extensive experience in the development of (in) vitro diagnostic devices, diagnostic tests, bio-pharmaceutical products and drugs and therefore can provide guidance where and how to start.

Some keywords:
IVD directive, IVDD, IVDMD, IVD regulations, IVDR, MD directive, MDD, MD regulations, MDR, GMP, GCP, GLP, Standards, ISO, CLSI, ICH.

Do you want to be prepared for the new IVD regulations? Did you know that the European IVD directive 89/79/EC is soon going to be replaced by the European IVD regulations? Did you know that the changes of the regulations will increase the risk classification of the majority of IVD assays?

And therefore impact the type and amount of evidence required in the technical file and the need for certification by a notified body?

Did you know that (most) diagnostic tests developed in hospital laboratories also need to comply with the IVD directive 89/79/EC, that they need CE-marking when put into service and that this will become more pronounced in the upcoming European IVD regulations (final version expected to be published and become effective in 2016)?

B-liss has extensive experience in the development of complex (in-vitro) diagnostic tests and the CE-marking thereof and therefore can provide guidance how to meet the directive and regulations.

Some keywords:
IVD directive, IVDD, IVDMD, IVD regulations, IVDR, CE registration