Documentation and Training Make the Difference
In highly regulated industries, compliance and quality assurance are essential to success. Process and product documentation help manufacturers meet regulatory standards and mitigate risk. Additionally, in today’s digital world, information security is crucial to compliance and protection of electronic data security.
For over 30 years, Novatek's team of experts has been creating technical documentation and training materials necessary to meet compliance, prepare for an audit or inspection, and be equipped to handle a cyber security incident.
Prepare for your upcoming product launch with this checklist.
With highly fragmented markets, short lifecycles and costs of quality issues, missteps and missed opportunities have a direct impact on revenue and margin. That's where Novatek's experts come in, producing materials that deliver on companies' needs for compliance, usability, reputation, and cost.
Learn more about our market expertise in medical device, manufacturing, and cyber security.
Novatek's knowledge and experience make for an ideal partner to plan, design, and develop documentation and training to manage risks.
How Novatek Helps
- Transition to EU MDR MEDDEV 2.7.1 Revision 4 (Clinical Evaluation Reports)
- Meet labeling requirements with Directions for Use/ Instructions for Use (21 CFR 801)
- Achieve quality system compliance with documented procedures (21 CFR 820)
- Establish process protection through documentation
- Produce up to date Standard Operating Procedures
- Create a quality management system to address regulatory compliance
- Meet quality requirements for ISO 13485, ISO 27001, MIL-SPEC
- Create user/operator manuals
- Develop online or instructor-led training
- Provide clear, concise installation instructions
- Write service manuals and troubleshooting guides
- Ensure safe and accurate product use with customer training
- Onboard staff quickly with well-documented processes
- Deliver reference guides and tutorials for self-sufficiency & standard operating procedures
- Update user documentation as device uses evolve
- Outsource training & documentation to keep overhead lean
- Increase efficiency with breach protocol standards
- Avoid fines
- Reduce help desk calls
- Reduce field service deployments
- Avoid process scrutiny for adverse events
- Assess and eliminate gap analysis
- Reduce risk and process failure with quality system documentation maintenance
- Avoid errors due to outdated training
- Avoid ‘brain drain’ with a knowledge transfer plan
- Provide helpful documentation and training for positive customer experiences
- Avoid product recalls
- Avoid consent decree
- Provide user-friendly customer manuals and training for customer retention and loyalty
- Create competitive advantage with well-trained staff & documented best practices
- Avoid security setbacks
- Mitigate risk with proactively trained teams
Outsource your technical writing or training needs to our experienced team. Our approach to product and process quality documentation will help reduce risk and provide cost savings.