Our contract manufacturing services are suitable for a wide range of customers, from individuals with creative ideas to large, multinational organizations seeking to grow their production capabilities. Constantly seeking to improve effectiveness, save you time and reduce your costs, they include both Production Services and Consulting Services.
Legal Manufacturing Services
Legal manufacturing service is a turn key solution for established companies with new project or product to be launched or for medical start-up companies looking for the fast way to get products to market or for. We provide full service from production and QC to supporting documents.
Sky Medical a.s. specializes in servicing companies to achieve CE Marking certification and getting products to European market as fast as possible. Our legal manufacturing services include:
Development of manufacturing processes and related quality control and provides manufacturing platform for medical device production in ISO class 7 environment, including packaging integrity tests and sterile barrier validation
Technical File, labelling and UDI, and instruction for use creation / review to ensure compliance and consistency
Clinical evaluation and preclinical studies compliant with newest MedDev requirements
Risk assessment and management (ISO 14971) and evaluation of intended use
Transition to new MDR
A CE Marking Technical File is a comprehensive description of medical device intended to demonstrate compliance with European regulations. Compiling technical file is a critical step in CE Marking process and a requirement for compliance with the Medical Devices Directive 93/42/EEC or MDR 2017/745. Sky Medical assists in creating Technical File compliant with new MDR for new or existing medical devices in efficient and effective way enabling getting the device to the market as fast as possible.
Moreover, new Medical Devices Regulation (MDR 2017/745) will change CE Marking and Technical File requirements for medical devices. Sky Medical a.s. can assist with the efficient MDR transition process.
Our manufacturing expertise and infrastructure provides solid base for fast execution of new production line or transfer of existing production.
Private Label Services
Private labelling means to bring a product from another manufacturer onto the European market under your own brand name. When you are bringing a medical device onto the European market under your own name, you are the legal manufacturer. This means that you have the sole responsibility to ensure compliance of the medical device with the applicable legislation.
We offer a wide range of benchmark standard and customized disposable CE marked medical products. Our goal is to develop and manufacture healthcare products on demand to meet your market requirements and under your own brand. Our products are manufactured conform ISO 13485:2016 (GMP medical devices).
Private label means our CE mark (our responsibility) and your requirements resulted in custom made devices under your own name.
Product performance directly impacts goals and objectives and our technical support covers the finest services and support for your programs. Our qualified personnel provide a full-scale service for the establishment of medical device manufacturing facilities, ensuring that your infrastructure complies with all applicable standards and regulations and that processes work in the best possible way. Our technical support services include:
Building of Cleanrooms and Infrastructures
We provide complete turnkey projects for the establishment of medical device cleanroom production facilities and infrastructures. Services include the planning, realization and validation of cleanrooms using reliable and certified suppliers and materials. Read more about the ISO Class 8, 250 square meter cleanroom we built in Kazakhstan.
We provide consultant services for the establishment of ISO 13485:2016 QMS and related infrastructures. These services include:
- QMS gap analysis vs. ISO 13485:2016
- Establishment and implementation of QMS and related procedures
- Execution of internal and external audits
- Mapping of applicable regulatory requirements
- Establishment of material flows and infrastructures
- Risk assessments
- Validation of processes and products
Manufacturing Facility Operations Support
We support small and mid-size companies in focusing on their challenges in the establishment of manufacturing facility operations, in order to optimize time-to-market. Our support, which helps to deliver products more quickly, efficiently and cost-effectively to the healthcare professionals and patients who need them, includes the following services:
- Alignment of customer objectives with supply chain strategies
- Establishment and optimization of supply chains that ensure that client projects have the full attention of our senior personnel
- Monitoring of key milestones to ensure adherence to identified timelines and meeting key objectives for specific activities
- Inventory management
- ERP establishment and validation
Working With Us
7 Simple Steps to Deliver Turnkey Projects
Partner presents proposed project, including definition of purpose, needs and preferred delivery timetable.
Sky Medical evaluates the request, asks relevant questions, performs a risk assessment, formulates a solution and provides all relevant information and an initial proposal to the partner.
Once the initial proposal is finalized, a contract is drawn up between Sky Medical and the partner, detailing all the stages of the project, the milestones, the deliverables and the costs.
Once the contract is signed, development begins, including testing and validation, in order to produce a product ready for partner approval
Partner tests and reviews the product, ensures that is complies with all the requirements, and provides input for changes / approval for productio
Sky Medical starts production, according to the technical specifications, the quantities required and the timetable defined in the contract.
Product is delivered to the partner, or alternatively stored by Sky Medical until instructions are received from the partner concerning full or partial delivery.