OUR SERVICES
MEDICAL PRODUCTS
- Online/offline training on the requirements of the ISO 13485 international standard with the certificate issuance from the EU resident
- EN ISO 13485:2016 certification
- Assistance in the preparation and registration of technical documentation according to the rules MDR 2017/745, IVDR 2017/746
- Classification of medical products according to the requirements of 2017/745/EU
- Off-site/on-site seminars on EU MDR, IVDR with european training certificate
- Order translation of EU regulation 2017/745 into russian
- Registration in Eudamed (receiving SRN and UDI codes)
- Authorized representative
- Importer and distributor services
PHARMACEUTICAL AND FOOD PRODUCTS
- Trainings on GxP standards with the issuance of training certificates from the European organization
- Assistance in preparing documentation according to GDP rules
- EU GDP certification
- Transportation and distribution services
COSMETICS
- Assistance in the development and design of technical documentation, including safety report, according to the requirements of ISO 22716:2007 (GMP) and the legislation of the European Union
- Training in GMP/ISO 22716 with certification from EU resident company
- Registration of cosmetics in the CPNP register (EU Regulation 1223/2009)
- ISO 22716 and GMP certification
- Authorized representative service
EXTERNAL PROVIDER AUDIT
- Environment, Health and Safety (EHS)
- Food and industry
- Medical supplies, including critical items components and materials
- Control of production of goods, materials, components at the request of customers, Euro norm (CoP)
- QMS and CPS suppliers for compliance requirements of customers, trading networks, Euro norms
- Supply Chain Risk Management (PAS 7000)
- Corporate social responsibility audit (CSR)
- C-TPAT and Supply Chain Effectiveness
SUPPORT OF TESTING ACCORDING TO THE REGULATIONS
- 2009/1223 - Cosmetic Regulation
- 2011/305 (CPR) - Construction Products Regulation
- 2016/424 - Cable installations
- 2016/425 - Personal protective equipment
- 2017/745 (MDR) - Medical Device Regulation
- 2017/746 (IVDR) - In vitro diagnostics medical devices
FACILITATING THE ASSESSMENT OF COMPLIANCE WITH THE DIRECTIVES
- 2001/95 (GPSD) - General Product Safety Directive
- 2006/42/EU - Machinery and mechanisms
- 2011/65 (RoHS) - Restriction of Hazardous Substances in electrical and electronic equipment
- 2014/29 (SPVD) - Simple Pressure Vessels Directive
- 2014/30 (EMC) - Electromagnetic compatibility
- 2014/32 (MID) - Measuring instruments
- 2014/33/EU - Elevators and lifting mechanisms
- 2014/35 (LVD) - Low Voltage Directive
- 2014/53 (RED) - Radio equipment
- 2014/68 (PED) - Pressure equipment
- 2015/720 (94/62) - Packaging and waste packaging
ABOUT US
NIKAFORCE Sp. Z o. o., was created to help organizations of any field of activity to enter the market of the European Union and to carry out activities in its territory.
We named the company NIKAFORCE for a reason, multi-cored name allows to accurately reflect the essence of our activity - the goddess of victory NIKA has the necessary strength FORCE, to receive the cherished CE sign.
And it will not be an exaggeration, because we - NIKAFORCE, provide a full range of services by entering all European Union member markets:
- certification and registration of organizations and their products
- second-party audits (competent inspection of you and/or your suppliers)
- laboratory tests according to EN requirements (European Standards Committee)
- legal and logistical support
The key direction of our activity is preparation and support of certification of all types of products and companies according to European and international standards, namely:
- informational and consulting support
- assessment of the possibility of entering the European market - costs, timings, etc.
- training in the requirements of applicable standards and the provision of a translation of the European Union Medical Device Regulation (MDR)
- preparation and verification of documentation
- interaction with any European body to obtain documents necessary for export
Our key customers are manufacturers of medical and technological devices, cosmetic products. We also have positive experience in introducing construction and food products to the European market.
OUR CLIENTS
