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.
PRODUCT DEVELOPMENT & MANUFACTURING
We offer a range of products, from single-use medical devices to the assembly of complex, integrated devices, all produced according to the regulatory demands of medical and healthcare industries. We have an ISO Class 7 validated cleanroom which enables us to ensure the quality and sterility of every product that we manufacture, and we provide full-scale project management and technical support services to manage transfer processes. Examples of our range of medical devices and products include:
- Complex Tubing Sets for various medical procedures, such as IV therapy, nutrition, contrast media injection, cardiology, radiology, invasive blood pressure monitoring, cardioplegia and heart perfusion tubing.
- Catheters produced from polyurethane, PVC and silicone for various medical procedures, according to customer needs and specifications.
PACKAGING & LABELLING
To ensure safe and sterile medical devices, we use a range of packaging materials, including pouches and rigid packaging materials that maintain product integrity. We also have extensive experience in designing dedicated packaging for specific products, and work in close cooperation with leading thermoforming companies, ensuring that our customers receive their products packaged and validated according to all the relevant standards.
We provide sterilization and sterilization validation services through a subcontractor using ETO and E‑Beam technologies. The choice of the sterilization method depends on a number of factors, such as the material of the object to be sterilized, the number and type of microorganisms involved, the classification of the item and the availability of sterilization methods. The objective of sterilization validation is to determine that the sterilization process consistently achieves sterility and does not have an undesirable effect on the device or its packaging. Our services include technical support in determination of the sterilization process and validation of the execution of sterilization protocols, to determine compliance with the requirements of the valid standards.
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.