EU quality system requirements for medical devices
How Regulation (EU) 2017/745 requires manufacturers to run a quality management system, from design through surveillance, and who must oversee it.
How Regulation (EU) 2017/745 requires manufacturers to run a quality management system, from design through surveillance, and who must oversee it.
A working guide to genotype-guided drug response: which genes carry the signal, how to call star alleles yourself, and where arrays fail.
A practical guide to obtaining your own genome sequence: what to order, what coverage and file formats to insist on, what it costs, and how to pull reference gene sequences from public databases.
A practical pipeline for normalizing personal proteomics data, from raw intensity matrices through log transformation, method selection, batch correction, and longitudinal re-normalization when new draws arrive.
A step-by-step pipeline that turns your own whole-genome data into a normalized and annotated variant set, with the tools and filters we would use.
A step-by-step guide to going from FASTQ or CRAM to a filtered, annotated germline VCF on one human genome using BWA-MEM2, GATK4 HaplotypeCaller, and hard filters, with the failure modes that matter at n=1.
A step-by-step pipeline for turning bulk RNA-seq FASTQ files into a gene-level count matrix, differential expression results, and pathway scores, with the specific tools, flags, and QC thresholds we use.
A working account of what belongs in a comprehensive blood panel, which preanalytical variables move the numbers, and how to tell a real change from assay noise using biological variation and reference change values.
A technically specific guide to choosing a whole-genome test: what files you should demand, what coverage and platform choices change, and how to analyze the data yourself.
A technical account of exome sequencing: capture chemistry, coverage statistics, and the failure modes that decide between WES and WGS.
A step-by-step guide to turning your own blood RNA-seq FASTQ files into a normalized expression matrix, cell-type estimates, and pathway scores you can track across timepoints.
What goes into a 510(k), De Novo, PMA or HDE submission to FDA, with format rules and review timeframes.
A breakdown of WGS pricing by depth, platform, and deliverable, from $200 research-core genomes to $5,000 clinical reports, plus the downstream storage and compute costs nobody quotes.
One fasting glucose of 100 sits at the edge of a threshold that was drawn by committee, and a single draw carries more measurement noise than most people expect. Here is how to read the number, what to measure next, and how to analyze the data yourself.
The national bodies that regulate drugs, devices, reimbursement, genetic resources and personal data in China, and what provinces handle.
A practical walkthrough for calling and filtering copy number variants from a 30x whole-genome CRAM, with the limits of what each caller can see.
A working pipeline that turns raw CNV calls from a personal genome into an annotated and prioritized table, with visual confirmation.
A working pipeline for human exome data with BWA-MEM, GATK HaplotypeCaller and VEP, with the flags that matter and the failure modes.
The public genome sites worth using, what each is good for, and how to go from a reference genome to a file that describes your own.
A technical walkthrough of pharmacogenetic star-allele calling from whole-genome data: which genes have real evidence, why CYP2D6 breaks most pipelines, and how to read a diplotype-to-phenotype report without over-trusting it.