Whether you require product certifications or technical files and regulatory support, we provide a clear path forward to attain your goals with predictable outcomes and timelines.
Our services include:
- preparation of product launch roadmap with realistic milestones
- identification of applicable regulations and standards, including EMC requirements
- identification of required product modifications for targeted international markets
- liaison with country-specific regulatory agencies, notified bodies, representatives, and other stakeholders
- preparation of submission documents, technical files and other required documentation
- verification that the technical file, design dossier, etc., is complete and meets the agency’s submission requirements
- verification that the scope of testing is appropriate and meets the relevant regulations, standards, or Directives
Quality systems:
- ISO9001
- ISO13485
Canada:
- CSA C22.1 Canadian Electrical Code
- SOR /98-282 Medical Devices Regulations
- Health Canada medical device licensing and MDSAP
- Provincial safety authorities (ie ESA Ontario; Technical Safety BC, etc)
USA:
- NFPA70 National Electrical Code
- NFPA99 Health Care Facilities
- OSHA – 21 CFR 1910 Occupational Safety and Health Standards
- FDA – 21 CFR 820 Quality System Regulation and other medical devices regulations, 510(k) applications
- AHJ – Authority Having Jurisdiction
- UL, ANSI, AAMI Standards
EU:
- General Product Safety Directive 2001/95/EC
- Machinery Directive 2006/42/EC
- Waste Electrical and Electronic Equipment Directive – 2012/19/EU
- Battery and Battery Accumulator Directive – 2006/66/EU
- Packaging Directive – 94/62/EC
- Medical Devices Directive 93/42/EC
- Medical Devices Regulation 2017/745/EU
- IVD Regulation 2017/745/EU
- Radio Equipment Directive – 2014/53/EU
- General Data Protection Regulation – 2016/679/EU
- Environmental reporting and registration requirements
- EU Representative
- Notified Body
- Competent Authority
Other jurisdictions:
- National standards and regulations
- National regulatory bodies and safety authorities
- Import/export regulations
Contact us today to discuss your needs.