Complyit

Consultation in various areas including:

Review of marketing materials: Complyit offers a comprehensive review of marketing materials for medical devices. We can help ensure that your company’s marketing complies with applicable laws and regulations, and that it is accurate, clear, and credible. The review is tailored to your needs and product, including review of your website, printed materials, and social media posts. We assist in identifying and addressing any deficiencies in the material to meet the high standards required in the industry.

GxP: Good Practice (GxP) encompasses guidelines and regulations for the manufacturing of pharmaceuticals and other Life Science products to ensure product effectiveness and usability for the user. Various regulations such as Good Manufacturing Practice (GMP), Good Automated Manufacturing Practice (GAMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP) are applied throughout the product lifecycle. A common thread is Good Documentation Practice (GdocP). Complyit has consultants with expertise in adhering to and achieving these regulations to ensure manufacturing and quality control maintain high quality and consistently deliver safe products.

Financing: Limited resources and lack of funding pose challenges, especially for smaller companies, due to increasing regulatory requirements. However, there are grants available that can have a significant impact on your business. We can help identify and apply for these grants. Our goal is not only to provide expertise but also to guide you through the application process and increase your chances of securing the necessary funds.

ATMP: Advanced Therapy Medicinal Products (ATMP) are biological drugs based on cells, tissues, and genes. ATMP includes drugs for somatic cell therapy, gene therapy, tissue engineering products, and combination drugs when one or more medical devices are integrated into the drug. Do you have a potential product but are unsure how to proceed? We help you gain a better understanding of the regulatory requirements from the idea stage to the use of your product within the hospital exemption/market approval. Based on your product, we create an overall process map with necessary project steps and stakeholders, providing tools to systematically evaluate risks associated with your product idea and description, and assisting in advancing your product project.

We also assist with regulatory analysis and develop a regulatory plan, identifying the regulations that apply to your product at various stages in your project. This regulatory information can be used, for example, in an application for the classification of your product, processed and evaluated by the Committee for Advanced Therapy (CAT) affiliated with the European Medicines Agency

Complyit Concepts CE marking

This concept is aimed at companies that manufacture medical devices and who need a guide to CE marking. Complyit offers a 20% discount for UIC companies.

When developing a product, it is necessary to determine whether the product needs to be CE marked. CE marking examines which risk class the product belongs to, and which regulations that needs to be followed, what classification the product receives and what type of documentation is needed. If the product does not meet the definition of a medical device, we identify other applicable standards and regulations. We have consultants who can support you, e.g. by gradually producing an advisory guide on what applies to your particular product. We offer Complyit Concepts CE marking, where we break down the requirements into three parts and lead you right into the regulatory jungle.

Part 1 Regulatory analysis: Qualification, classification and plan for activities.

Regulatory analysis to evaluate the work required to CE mark and meet the requirements for applicable regulations (MDR (EU) 2017/745, Medical Device Regulation or IVDR (EU) 2017/746, In Vitro Diagnostic Medical Device Regulation).

Fixed price SEK 53 000 ex. VAT – after discount 42 400 SEK ex. VAT

Part 2 Applicable requirements: Subsequent work when part 1 Regulatory analysis is performed.

The development of a Technical Documentation (TD) Summary and GSPR checklist that presents applicable requirements for applicable regulations as well as standards and methods that should be used to achieve the requirements.

Fixed price 165 000 SEK ex. VAT – after discount 132 000 SEK ex VAT

Part 3 Adapted to your need for help going forward.

For example, in-depth analyzes, writing technical documentation, establishing quality management systems, assistance with selection of notified body and communication with notified body, internal audit / mock inspection as preparation for third-party review.

Examples of roles: Senior QA / RA, Project Manager, Junior Quality Engineer etc

Price based on the scope of the assignment. UIC companies receive a 20% discount.

Extra hands

Sometimes we have consultants between assignments, run relatively newly graduated civil engineers, chemists or the like, some even with a PhD. They really want to work, so when available, they can instead be a pool of skills, energy and maybe sometimes just a few extra hands for UIC companies. They can support UIC companies for a shorter period, for a symbolic sum, depending on the need.

Courses/Training
Complyit offers tailor-made training in all areas that we provide consulting services – such as GMP, ISO 13485, MDR, IVDR, and validation.