Question 1

What type of laboratory investments does this tool support?

Accepted Answer

The tool covers 6 laboratory segments: Clinical Diagnostics, Food Safety, Pharmaceutical, Oil & Gas, Chemical, and Forensic Science. Each has a specialized questionnaire, instrument database, and industry benchmarks. The resulting Investment Memorandum includes equipment recommendations, CAPEX/OPEX analysis, staffing, real estate assessment, and workflow optimization.

Question 2

Do I need a clean room for my laboratory?

Accepted Answer

Not every laboratory needs a clean room. Basic QC and analytical labs operate under ISO 17025 or GLP without classified environments. Clean rooms become mandatory when your processes involve sterile pharmaceutical manufacturing, aseptic filling, or medical device assembly. Our Environment Level Assessment helps you determine exactly which classification applies to your facility.

Question 3

What is ISO 13485 and does it apply to me?

Accepted Answer

ISO 13485 is the quality management standard for medical device manufacturers. If you design, produce, install, or service medical devices, you need ISO 13485 certification. This typically requires at minimum a controlled environment (ISO 8 / Grade D). Our framework maps the specific requirements to your product type and regulatory market.

Question 4

What certifications and standards does the framework cover?

Accepted Answer

The framework covers 5 major regulatory families: ISO 17025 (testing labs), ISO 13485 (medical devices), ISO 14644 (cleanroom classification), EU GMP Annex 1 2022 (sterile pharma), and FDA 21 CFR 210/211 (US pharma). Additional coverage includes WHO TRS 937, PIC/S, and GLP for specific lab types.

Question 5

Is the service really free?

Accepted Answer

Yes, completely free with no obligations. The Investment Memorandum is a consulting-grade document that would typically cost €5,000–€15,000 from a traditional consultancy. We offer it free because we believe better-planned laboratories lead to better procurement decisions. Your data is confidential and never shared with vendors.