About Us
This is Sky Medical
A contract manufacturer of medical devices, offering full-scale services from initial runs of prototypes to large volume production, including product assembly, packaging, sterilization, storage and logistics.
We are agile and responsive to our OEM partner needs, and have developed robust quality systems since our leadership comes from OEM backgrounds. Our services are based on extensive experience and knowhow of more than 20 years in the medical device manufacturing and distribution market. Our location in the Slovak Republic offers excellent access to the European market and enables us to offer significant cost reductions and efficient supply chain services.
All these benefits come without the bureaucracy of a large company, or the financial risk associated with a manufacturer serving a few key clients. We understand that we are not just manufacturers of products, but are producing components and devices that will be used to save or enhance a patient's life. Consequently, we are committed to the highest quality standards in everything we do.
We work with our OEM partners to understand and achieve their goals. We listen to their needs and seek to create lasting and profitable partnerships. We pride ourselves on our flexibility, and are agile in our integration, project management, responsiveness and prices.
Our Value Proposition
Quality Assurance
Sky Medical a.s. is comitted to provide high quality service in medical device field, including manufacturing of innovative life-enhancing medical devices in compliance with ISO 13485 and relevant regulatory requirements to ensure safety to the patient and caregiver.
We maintain the effectiveness of our quality system by continually pursuing measurable objectives related to:
-
Processes and infrastructure development and improvement: Seeking for opportunities to improve manufacturing processes performance by employees’ involvement and technological innovation, development and maintaining of infrastructure, minimizing risks of production processes on safety and performance of products.
-
Quality system effectiveness and risk reduction: Effective usage of tools and methods of quality management and ERP tool to continuously monitor processes´ effectiveness and efficiency to reduce risks.
-
Supplier quality assurance: Building effective network of suppliers, continually monitor their performance, and improve purchased products and services quality based on establishing of structured supplier evaluation.
-
Personnel awareness and competence: Promoting awareness, competence and skills of all the employees by establishing effective training program and motivation system.
-
Regulatory compliance: Precise mapping of applicable regulatory requirements and maintaining system to continuously meeting them.
-
Customer focus and flexibility: Creating a continuous improvement culture to provide products and services offered to the customers such as, production technology, production planning, product delivery, product quality, logistics network and other services.
EC TF01 Certificate DD 60142754
EC TF02 Certificate HD 60142755
Sky Medical_ISO 13485 Certificate 39 05 0251902
Leadership Team
Our leadership team has extensive experience and expertise in the medical device market.
Amos Nahir
Chairman
Amos served for more than 18 years as the Managing Director of Degania Silicone Ltd., a world-class manufacturer of indwelling medical catheters and a contract manufacturer of medical catheters servicing many leading multinational medical companies. He gained his professional expertise in several top management positions, including CEO of Chromagen (Israel) and Tali Ltd. (UK), and Chairman of the Board for several Degania Silicone subsidiaries. Amos has also been active in medical start-ups, and was the co-founder and director of AngioSlide Ltd. and EndoCross Ltd. He has a BA in Economics and Business.
Barak Lavi
Director, Business Development
Barak understands that business development is about being present, relevant and adding value. A firm believer in caring for both company and customer interests, he is a focused, motivated and result-oriented executive with more than 20 years of experience in medical device companies. This experience includes serving as a VP Marketing & Sales and establishing and managing global distribution chains. In Sky Medical, Barak’s job is to understand our customers – their pains, their goals and their needs – and to accompany them on their journey to optimal, cost-effective solutions and a fruitful partnership with Sky Medical. Barak has a MA in Technology Management, a BSc in Polymer and Plastic Engineering and a BA in Life Sciences.
Pavel Grinshpun
Managing Director
Pavel is an innovative leader, illustrated in more than 15 years of experience in management, operations and production positions where he nurtured technological innovations into successful products. He is an inspiring, eloquent and creative leader, highly respected both as a person and a professional. Prior to Sky Medical, Pavel established and managed a medical device manufacturing company in the Slovak Republic. In Sky Medical, he is responsible for the management and operation of the company’s medical device production facility. Pavel has a BA in Business Administration.
Yulia Surinova
General Manager
Yulia is an experienced medical device industry professional. An expert in ISO 13485, MDR and problem solving, she has more than 15 years of experience in quality and industrial management. She has proven experience in establishment of medical device manufacturing infrastructure, clean rooms, material flow, building cross-functional teams within organization, development and certification of organization's RA strategy and management systems. Lean enthusiast. She has a BA in Quality Engineering and PhD in Industrial Management. She is a Vice President of Slovak Society for Quality and Medical device industry expert in Slovak National Accreditation institute.