Consultancy services
Services
Consultancy services tailored to your needs
Services
LEAN Compliance
Skilled and dedicated consultants
Our consulting team consists of unique profiles with a good business understanding who are able to implement the industry's regulatory requirements in a pragmatic way.
LEAN Compliance
Skilled and dedicated consultants
Our consulting team consists of unique profiles with a good business understanding, who manage to implement the industry's regulatory requirements in a pragmatic way.
Regulatory Affairs
Regulatory advice and strategic planning.
- Regulatory strategy planning
- MDR/IVDR gap analysis
- Definition of 'intended purpose' and product classification
- Preparation of technical documentation for product registration
- Product registration
- Government Communication
- Ad hoc regulatory support
- Person Responsible for Regulatory Compliance (PRRC)
Quality Assurance & Control
Implementation of quality management systems and auditing.
- Development and implementation of quality management systems (QMS) in accordance with ISO9001, ISO13485, 21 CFR 820
- ISO9001 and ISO13485 gap analyses
- Auditing and back office support
- Supplier management - quality agreements and auditing
- Incoming inspection and quality control
- QA production support - CAPAs, NCRs, and Change Requests
- Qualification of equipment
- Process and test method validation
- Batch review and release
- QP's - Qualified Person(s)
Design Control
Project management from idea to product.
- Risk management, ISO14971
- Requirements specifications
- Design inputs/outputs
- Design verification and validation
- Design reviews
- Software development and validation, EN62304
Clinical & Performance
Preparation of clinical and performance evaluations.
- Literature search protocols and criteria
- Scientific validity reports
- Analytical performance reports
- Clinical/Performance study plans and reports
- Post-Market clinical/performance follow up plans and reports
Post-Market Surveillance & Vigilance
Implementation of PMS systems and vigilance reporting.
- PMS plans
- PMS reports and PSURs
- FSCAs and recalls
- Incident and adverse event reporting
- Trend reporting
Business Consulting
QA/RA management, Change management and LEAN.
- Project Management
- QA/RA interim management
- Change management
- Corporate Strategies
- LEAN management
Distributor or importer?
Understand with the new regulatory requirements for distributors and importers
With the implementation of MDR and IVDR, the requirements for distributors and importers of CE marked products have increased significantly. This should help to ensure traceability and reduce the risks associated with non-compliant equipment.
For distributors and importers, this means extra time and costs. LEAN compliance can help you implement the new regulatory requirements through simple procedures. We are also happy to help you develop and implement quality management systems tailored to your business needs.
Distributor or importer?
Understand with the new regulatory requirements for distributors and importers
With the implementation of MDR and IVDR, the requirements for distributors and importers of CE marked products have increased significantly. This should help to ensure traceability and reduce the risks associated with non-compliant equipment.
For distributors and importers, this means extra time and costs. LEAN Compliance can help you implement the new regulatory requirements through simple procedures. We are also happy to help you develop and implement quality management systems tailored to your company's needs.
Need emergency support?
Compliance hotline
LEAN Compliance offers a daily online hotline service that allows your company and your employees to get urgent support or answers to questions in the field of legislation and guidance on. development, production and marketing of medical devices and in vitro diagnostics. We can also help with smaller one-off tasks, such as reviewing documentation and procedures or reviewing reports.
This allows an on demand ad hoc consultancy support with no commitment. Invoicing is thus exclusively for the time spent by the consultant on the specific task
If you want to know more about our compliance hotline or if you have an urgent problem, don't hesitate to contact us.
I'm not afraid to challenge the nursing concept. My mission in starting up a consultancy is to do away with today's so-called "skilled complicators".
Pernille Eilersen
Adm. Director
LEAN Compliance ApS
mail@leancompliance.dk
+45 60 61 20 82
CVR: 42598224